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Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial
J Shoulder Elbow Surg (2011) 20, 747-755
www.elsevier.com/locate/ymse
SHOULDER
Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial Per Olerud, MDa,*, Leif Ahrengart, MD, PhDa, Sari Ponzer, MD, PhDa, Jenny Saving, MDa, Jan Tidermark, MD, PhDa,b a
Karolinska Institutet, Department of Clinical Science and Education, Section of Orthopaedics, Stockholm S€oder Hospital, Sweden b Department of Orthopaedics, Capio S:t G€ orans Hospital, Stockholm, Sweden Background: The aim of the study was to report the 2-year outcome after a displaced 3-part fracture of the proximal humerus in elderly patients randomized to treatment with a locking plate or nonoperative treatment. Patients and methods: We included 60 patients, mean age 74 years (range, 56-92), 81% being women. The main outcome measures were the Constant and Disabilities of the Arm, Shoulder and Hand (DASH) scores and the health-related quality of life (HRQoL) according to the EQ-5D. Results: At the final 2-year follow-up, the results for range of motion (ROM), function and HRQoL were all in favor of the locking plate group. The mean flexion in the locking plate group was 120 compared to 111 in the nonoperative group (P ¼ .36) and the mean abduction was 114 compared to 106 (P ¼ .28). The corresponding values for the Constant score were 61 versus 58 (P ¼ .64), for DASH 26 versus 35 (P ¼ .19), and the mean EQ-5D index score was 0.70 compared to 0.59 (P ¼ .26). In spite of good primary reduction in 86% of the fractures in the locking plate group, 13% of the patients had a fracture complication requiring a major reoperation and 17% had a minor reoperation. Conclusion: The results of our study indicate an advantage in functional outcome and HRQoL in favor of the locking plate compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus, but at the cost of additional surgery in 30% of the patients. Level of evidence: Level I, Randomized Controlled Trial, Treatment Study. Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Proximal humeral fractures; internal fixation; elderly; functional outcome; quality of life
The study was supported in part by grants from the Trygg-Hansa Insurance Company and the Stockholm County Council. The study was approved by the Local Ethics Committee in Huddinge, Stockholm, Sweden (number 342/02). The study was conducted according to the principles of the Helsinki Declaration. All patients gave their informed consent to participate in the
study and the protocol was approved by the Local Ethics Committee in Huddinge, Stockholm, Sweden (number 342/02). *Reprint requests: Per Olerud, MD, Department of Orthopaedics, Stockholm S€oder Hospital, S - 118 83 Stockholm, Sweden. E-mail address: [email protected] (P. Olerud).
1058-2746/$ - see front matter Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. doi:10.1016/j.jse.2010.12.018
748 The proximal humeral fracture is the third most common fracture in elderly patients after fractures in the hip and distal radius1 and it is strongly associated with osteoporosis. The vast majority of the fractures are undisplaced or minimally displaced11 and can be treated nonoperatively.16 The most frequently used classification for proximal humeral fractures is the Neer classification.28,29 This classification is based on the 4 anatomical segments of the proximal humerusdthe humeral head, shaft, and the greater and lesser tuberclesdand whether these segments are fractured and displaced. The surgical neck 3-part fracture is defined as a fracture with at least 10 mm of displacement and/or 45 of angulation between the head and shaft fragments and a fracture of the greater or lesser tubercle with at least 10 mm of displacement. The 3-part proximal humeral fracture accounts for approximately 10% of all proximal humeral fractures.11 Operative treatment of displaced 3-part fractures in younger patients is not controversial. The main controversy pertains to elderly patients with varying degrees of osteoporosis and displaced fractures sustained after low-energy trauma. In this patient group, there is little evidence and poor consensus regarding the optimal treatment modality.19 The availability of modern orthopaedic implants such as locking plates with improved purchase in osteoporotic bone has contributed to a trend towards more frequent surgical interventions. Open reduction and internal fixation with locking plates have the potential to restore the anatomy in an excellent manner; but, there is a risk of complications related to both the implant3,14,20,22 and the surgery itself.6,30 Conservative treatment with short immobilization and early physiotherapy is a noninvasive, simple, and safe option, and acceptable results after nonoperative treatment have been reported.11,21,35 To the best of our knowledge, there are only 2 previous randomized controlled trials (RCTs) comparing internal fixation with nonoperative treatment in patients with proximal humeral fractures. The first study was done by Zyto et al, who in 1997 reported the outcome of nonoperative treatment compared with tension band wiring in 40 patients with displaced 3- and 4-part fractures.36 The second was a recently published study by Fjalestad et al,15 including 50 patients with displaced 3- and 4-part fractures comparing nonoperative treatment with a locking plate with a 12-month follow-up. However, the single paper from this trial published so far is focused on quality-adjusted life years (QALYs) and societal costs. No differences regarding these aspects were reported. The latest Cochrane review (systematic review of randomized controlled trials [RCTs]) regarding this topic19 concludes that there is insufficient evidence from RCTs to determine which interventions are the most appropriate for the different types of proximal humeral fractures. The limited evidence available does not confirm that surgery is preferable to conservative treatment, and complications associated with surgery need to be considered. Consequently,
P. Olerud et al. there is a need for future RCTs to more clearly define the role and type of surgical intervention. The aim of this study was to report the outcome after a displaced 3-part fracture of the proximal humerus in elderly patients allocated to treatment with a locking plate or nonoperative treatment in an RCT with a 2-year followup. The primary aim was to report the health-related quality of life (HRQoL) according to EQ-5Dä (EuroQol Group, Rotterdam, the Netherlands), while our secondary aims were to report the functional outcome according to the Constant and DASH scores.
Patients and methods Patients In an RCT with a 2-year follow-up, we included 60 patients with an acute displaced 3-part fracture of the surgical neck of the humerus, according to the classification of Neer,28,29 allocated to treatment with open reduction and internal fixation with a locking plate or nonoperative treatment between April 2003 and March 2008. The fracture inclusion criteria, based on conventional radiographs and computer tomography, were a displacement of the shaft of more than 10 mm and/or >45 of angulation in relation to the head fragment, combined with a displacement of the greater or lesser tubercle of more than 10 mm in relation to the head fragment. A minimally displaced/undisplaced fracture of the other tubercle, such as not meeting the criteria to be considered a separate fracture segment according to Neer, was not considered to be an exclusion criterion. Patients with a completely displaced shaft in relation to the head fragment, such as a fracture without bony contact, were considered to present an absolute indication for surgery and, therefore, were not included, nor were patients with a valgus impact fracture.10,33 The patient inclusion criteria were age 55 or older, a fracture sustained after a low-energy trauma (ie, simple fall), no previous shoulder problems, independent living conditions (ie, not institutionalized), and no severe cognitive dysfunction (ie, 3 correct answers on a 10-item Short Portable Mental Status Questionnaire [SPMSQ]).32 After clearance by an anesthetist, the patients were randomized (independently prepared opaque, sealed envelopes) to open reduction and internal fixation with a locking plate or nonoperative treatment.
Surgical intervention and nonoperative treatment All operations in patients randomized to surgery were performed by 1 of 2 orthopaedic surgeons, both well experienced in shoulder surgery, and the operations were performed within a mean of 6 (SD 4.1) days after the injury. All patients were given 2 g cloxacillin (Ekvacillinâ; AstraZeneca, S€ odert€alje, Sweden) preoperatively. The Philosâ plate (Synthes, Stockholm, Sweden) was used in all patients. This plate is anatomically shaped and is recommended to be placed at least 8 mm distal to the upper end of the greater tubercle (rotator cuff insertion) and slightly dorsal to the long head of biceps. It allows for 9 locking screws in the proximal fragment and is available in different lengths, allowing either locked or nonlocked screws in the shaft. The surgery was
RCT 3-part proximal humeral fractures performed in a modified beach-chair position utilizing a deltopectoral approach. Fractures of the lesser and/or greater tubercle with displacement and/or instability were fixed with nonabsorbable sutures. The reduction and position of the implant was checked with the aid of an X-ray image intensifier. The duration of surgery was recorded. The head/shaft angle, dorsal/ventral angle, and distance between the superior border of the greater tubercle and vertex of the head were measured postoperatively.22 Additionally, the position and utilization of the plate was recorded, such as the distance from the top of the greater tubercle, length of the plate (3 or 5 holes), number of screws in the head fragment, and if there was any screw penetrating the humeral head. After surgery, the arm was placed in a sling and all patients were referred to a physiotherapist. The sling was used for 4 weeks; afterwards, the patients were allowed to use it at their own convenience. Pendulum exercises and passive elevation/abduction up to 90 were started from the first postoperative day. After 4 weeks, the patients were allowed a free active range of motion (ROM). The fracture reduction and implant position were assessed using the postoperative radiographs. Nonoperatively treated patients had their arm immobilized in a sling for 2 weeks, after which time they were allowed to use it at their own convenience. After 2 weeks, the patients were referred to a physiotherapist, and pendulum exercises and passive elevation/abduction up to 90 were started. After 4 weeks, they were allowed a free active ROM.
Primary assessment and follow-up Besides classification of the fracture type according to Neer, as described above, assessments of cognitive function according to the SPMSQ32 and of general health according to the ASA classification31 were performed. Moreover, the patients were interviewed about their living conditions and their activities of daily living (ADL) status,25 and were also asked to rate their HRQoL according to the EQ-5D2 during the last week before the fracture as baseline (recall). Height and weight were measured, and body mass index (kg/m2) was calculated. Bone mineral density (BMD) was measured by dual-emission X-ray absorptiometry (DXA) with a Lunarâ densitometer (Lunar, Madison, WI). The patients were summoned at 4 months (mean 4.2, SD 0.8), 12 months (mean 12.3, SD 0.7), and 24 months (mean 25.3, SD 2.8). The final 24-month follow-up was performed by an independent orthopaedic surgeon not previously involved in the treatment. In the outcome analyses, all patients remained in their randomization group regardless of secondary procedures according to the intention-to-treat principle. Each follow-up included an X-ray check-up with a standardized frontal and lateral projection. In the locking plate group, we assessed fracture healing and redisplacement with changes in the head/shaft angle and dorsal/ventral angle. Furthermore, any additional screws penetrating the head or loosening of the plate were recorded. In the nonoperative group, we assessed fracture healing, including the position in which the fracture finally healed (ie, head/shaft angle, dorsal/ventral angle), and the distance between the superior border of the greater tubercle and vertex of the head.22 In both groups, any signs of avascular necrosis (AVN) and post-traumatic osteoarthritis (OA) were recorded. Additional operations after primary treatment, including the indication and date of the operation, were recorded. The
749 functional outcome was assessed using the Constant8,9 and DASH scores,23 while HRQoL was assessed using the EQ-5D.12
Methods Pain was assessed on a visual analogue scale (Visual Analog Scale [VAS] scores, 0e100: 0 ¼ no pain; 100 ¼ worst possible pain). The Constant score8,9 is a widely used system for measuring shoulder function regardless of the diagnosis. The normal population values depend on age, gender, and activity level of the patient.7 The best possible score is 100 and includes an assessment of shoulder function in 4 dimensions: pain (15), activities of daily living (ADL) (20), ROM (40), and strength (25). In the strength assessment, we followed the recommendations of Constant et al8; ie, patients who were unable to achieve the test position of 90 were assigned a strength score of 0. The DASH23 questionnaire is a region-specific outcome instrument developed to measure upper extremity disability and symptoms. The main part, the 30-item disability/symptom scale, was used in this study. The scores from each of the items are used to calculate a scale score (DASH score) ranging from 0 (no disability) to 100 (most severe disability). The HRQoL was rated using the EQ-5D.2 The EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is divided into 3 of severity: no problem, some problems, and major problems. An EQ-5D index score of 0 indicated the worst possible state of health and a score of 1 the best possible.
Sample size At the time when the study was planned (2002) there was only 1 published RCT comparing nonoperative treatment with internal fixation.36 Moreover, there were not yet any published papers reporting the outcome after treatment with locking plates. Finally, there were no available data for the primary outcome measure used in this study (ie, the EQ-5D) in patients with proximal humeral fractures. Therefore, we did not have any reliable data allowing us to perform a formal power analysis, but we made an estimation of power based on assumptions. The estimation indicated that a sample size of 60 patients would be sufficient.
Statistical analysis The statistical software used was SPSS 18.0 for Windows (IBM Corporation, Somers, NY). Scale variables and ordinal variables were tested using the Mann-Whitney U test. The Wilcoxon signed-ranks test was used to compare the EQ-5D between before fracture and at follow-ups. Nominal variables were tested using the chi-square or Fisher’s exact test. All tests were 2-sided. The results were considered significant at P < .05. In order to maximize the power of the statistical tests, we did not apply any correction factor to the P values (eg, Bonferroni correction), which may increase the possibility of a type I error.
Results A flow chart for all patients included is shown in Figure 1. One patient in the nonoperative group opted to be excluded
750
P. Olerud et al. Included patients 60
Randomized to LP 30 Operated with LP 29 Operated with HA 1 Deceased 2 Lost to f-u 1 Available at 4 mth f-u 27
Deceased (cum) 2 Lost to f-u 1 Available at 12 mth f-u 27
Deceased (cum) 2 Lost to f-u 1
Available at 24 mth f-u 27
Randomized to NO 30 Treated non-operatively 29 Opted to be excluded 1 Deceased 0 Lost to f-u 0 Available at 4 mth f-u 29
Deceased (cum) 1 Lost to f-u 1 Available at 12 mth f-u 27
Deceased (cum) 2 Lost to f-u 1
Available at 24 mth f-u 26
Figure 1 Flowchart for all patients included (n ¼ 60). LP, locking plate; NO, nonoperative; HA, hemiarthroplasty.
from the study after randomization and 1 patient in the locking plate group was treated with a primary hemiarthroplasty (HA). According to the radiological examinations, this patient had a 3-part fracture with a displaced greater tubercle and a minimally displaced lesser tubercle (2 mm), but at surgery a displacement of both tubercles exceeding 10 mm was diagnosed; ie, it was a true 4-part fracture according to the Neer classification. This patient died after 2.5 months due to causes not related to surgery. The overall mortality rate at 24 months was 7% (4 out of 59): 2 out of 30 in the locking plate group and 2 out of 29 in the nonoperative group. One patient in each group was lost to the final follow-up (Fig. 1). Baseline data for all patients included in relation to randomization group (n ¼ 59) are displayed in Table I. The mean age for all patients was 73.9 years and 81% of them were females. The mean age was 75.1 years for women and 68.7 years for men. The injured shoulder was in the nondominant arm in 35 patients (59%). The mean EQ-5D index score before fracture was 0.85 and the vast majority of the patients, 98%, were assessed as ADL A or B; ie, they were either independent in all 6 functions of ADL or independent in all but 1. According to the inclusion criteria, there were no patients with severe cognitive dysfunction (SPMSQ < 3) and all patients came from independent living conditions. The mean DXA total body T-score was 1.4 and 15 out of 59 patients (25%) had a T-score of more than 2.5 SD below the mean for young adults, and, consequently, satisfied the criteria for osteoporosis
according to the WHO definition.24 The vast majority of the fractures, 58 out of 59 (98%), were 3-part fractures with a displaced greater tubercle. Twenty-five (43%) of these fractures had an associated undisplaced or minimally displaced lesser tubercle. The lesser tubercle was undisplaced in 9 patients and displaced 1 mm in 5, 2 mm in 4, 3 mm in 4, and 5 mm in 3 patients. The single 3-part fracture with a displaced lesser tubercle had no fracture of the greater tubercle.
Clinical and radiological outcome In the locking plate group, the mean duration of surgery was 97 minutes (range, 52e181). The assessment of the postoperative fracture reduction showed a mean head/shaft angle (frontal projection) of 129 (range, 106e150 ), a mean dorsal/ventral angle (lateral projection) of 9 (10 e30 ), and a mean distance between the greater tubercle and the vertex of the head of 3 mm (5e15). A good reduction22 (ie, a head/shaft angle of 135 20 and a dorsal/ventral angle of 0 25 ) was achieved in 25 patients (86%). The plate was positioned at a mean of 7 mm (4e22) below the top of the greater tubercle, and a 3-hole plate was utilized in 26 patients and a 5-hole one in the remaining 3. The mean number of screws in the head fragment was 7 (4e8). A screw penetration of the head was found on the postoperative radiograph in 5 patients (17%). The penetration was 1 mm in 3 patients, 2 mm in 1, and 3 mm in 1. The fracture position was unchanged in 20 of the 26 patients (77%) available at 4 months and not reoperated. In 6 patients (23%), the head/shaft angle had decreased by a mean of 10 (range, 3e23 ). Additionally, in 4 of these 6 patients, there was also a mean increase in dorsal angulation of 13 (range, 2e28 ). Additional screw penetration of the head had occurred at 4 months in 3 of the 26 patients (12%) at risk. All secondary screw penetrations occurred in patients with a changed fracture position. There was a secondary displacement of the greater tubercle before the 4-month follow-up in 4 of the 25 patients (16%) at risk with a mean of 18 mm (range, 2e30). The single 3-part fracture with a displaced lesser tubercle showed no detectable secondary displacement. There were no additional changes in fracture position and no additional screw penetrations in any of the patients after the 4-month follow-up. Three patients (10%) in the locking plate group displayed signs of AVN: 2 minor and 1 severe, 2 of whom were reoperated. In the locking plate group, 9 patients (30%) had additional surgery during the 2-year follow-up period (Table II). Four patients (13%) required major additional surgery: 1 due to a primary infection; 1 due to haematogenous infection; 1 due to nonunion; and 1 due to severe AVN. Five patients (17%) had minor additional surgery, all during the second year, with removal of the plate and release of adhesions. The indication for surgery was secondary screw penetration in 1 patient, postoperative
RCT 3-part proximal humeral fractures Table I
751
Baseline data for all patients included in relation to randomisation group (n ¼ 59)
Mean (range) age in years Gender, female, n (%) Mean (range) cognitive function Mean (range) EQ-5Dindex score prefracture ADL A and B, n (%) Nondominant arm, n (%) Mean BMI (kg/m2) Mean (SD) DXA total body T score Fx type 3-part with displaced GT 3-part with displaced LT
Locking plate n ¼ 30
Nonoperative n ¼ 29
P
72.9 24 9.4 0.85 29 19 26.6 1.3
74.9 24 9.2 0.85 29 16 25.9 1.4
.26 .79 .25 .35 1.0 .52 .59 .92 1.0
(56-92) (80) (5-10) (0.19-1.0) (97) (63) (19-37) (4.1-1.3)
29 (97) 1 (3)
(58-88) (83) (6-10) (0.41-1.0) (100) (55) (14-39) (4.3-1.6)
29 (100) 0 (0)
ADL, activities of daily living; DXA, dual-emission X-ray absorptiometry; Fx, fracture; GT, greater tubercle; LT, lesser tubercle.
stiffness in 2, and impingement in 2. All but 1 of these patients had improved function according to DASH between the 12- and 24-month follow-up with a mean of 6.2 points (range, 0e15.8). One patient in the nonoperative group had a nonunion. The other 28 fractures healed with a mean head/shaft angle (frontal projection) of 121 (range, 87e193 ), a mean dorsal/ ventral angle (lateral projection) of 48 (6e117 ) and a mean distance between the greater tubercle and the vertex of the head of 0 mm (8e20). Only 4 of the fractures (14%) healed in a position that satisfied the criteria for a good reduction.22 The patient with a nonunion opted to abstain from surgical intervention. A contributing factor to this decision was a late diagnosis of axillary nerve palsy. One patient (3%) had additional minor surgery during the 2-year follow, an arthroscopic acromioplasty due to impingement
Table II
resulting from a malunited greater tubercle (Table II). Moreover, 2 patients (7%) displayed signs of minor AVN and 1 patient (3%) had post-traumatic osteoarthritis.
Functional outcome and HRQoL The functional outcomes according to the Constant and DASH scores are displayed in Table III and the HRQoL (EQ-5Dindex score) in Figure 2. The figures for the Constant and DASH scores, as well as the EQ-5Dindex score, were all in favor of the locking plate group on all follow-up occasions, although not reaching statistical significance. The mean pain score according to VAS at the final followup was 17 in the locking plate group compared to 20 in the nonoperative group (P ¼ .94). The mean range of flexion at
Data on the 10 patients undergoing additional surgery after primary treatment
Group
Gender/age
Fx type
T-score
Reduction
No. of screws
Indication
Reoperation/reoperations
LP
M/58
3-GT
1.5
140 /12
8
Deep infection
LP
F/74
3-GT
4.1
115 /12
5
Nonunion
LP
F/67
3-GT
0
111 /3
8
Deep infection
NO LP LP
M/73 M/66 F/59
3-GT 3-GT 3-GT
0.6 2.3 1.2
NA 150 /6 123 /1
NA 6 8
LP LP LP LP
F/56 F/66 F/82 F /77
3-GT 3-GT 3-GT 3-GT
2.4 0.3 0.7 2.6
129 /3 131 /-10 130 /30 140 /10
7 8 8 7
Impingement Impingement Stiffness, sec. screw penetration Stiffness Stiffness AVN, minor AVN, severe
Wound revision, repeated lavage, extraction of plate and spacer Reosteosynthesis, LP þ autologous bone transplant Wound revision þ extraction of plate, healed fx Arthroscopic acromioplasty Extraction of plate, release Extraction of plate, release Extraction of plate, release Extraction of plate, release Extraction of plate, release Extraction of plate and hemiarthroplasty
Time
DASH 24 mos.
3.7
47.5
10.0
80.8
12.9
64.2
13.4 14.7 18.1
39.2 5.0 0.0
20.0 23.1 23.4 24.8
0.0 25.0 24.2 Missing
LP, locking plate; NO, nonoperative; M, male; F, female; Fx, fracture; GT, greater tubercle; Reduction, valgus angle/dorsal angle; No. of screws, no of head screws; Time, time elapsed from the primary operation or the start of nonoperative treatment in months; NA, not applicable; mos., months; AVN, avascular necrosis.
752
P. Olerud et al.
Table III The Constant and DASH scores (mean; SD) for all patients available at each follow-up (4 mos, n ¼ 56; 12 mos., n ¼ 54; 24 mos, n ¼ 53) 4 mos. LP Constant score (0e100) I. Pain (0e15) II. ADL (0e20) III. ROM (0e40) IV. Strength (0e25) DASH (100e0)
NO
52.3 (14.3)) 10.0 13.8 22.2 6.3 36.2
12 mos.
(3.6)) (4.0)) (6.4)) (4.3)) (22.4))
24 mos.
P
LP
NO
P
LP
NO
P
48.8 (16.3)
.48
61.5 (18.4))
56.8 (16.8)
.18
61.0 (19.2)
58.4 (23.1)
.64
9.5 12.8 20.6 6.0 35.7
.48 .42 .61 .64 .85
11.9 14.9 27.0 7.6 29.1
10.6 14.2 24.1 8.0 35.1
.15 .52 .11 .97 .32
12.4 14.1 27.3 7.3 26.4
11.2 14.6 24.7 7.9 35.0
.12 .75 .41 .88 .19
(3.4) (4.9) (8.2) (4.3) (20.1))
(3.2)) (5.0)) (8.7)) (4.7)) (23.3)
(3.5) (5.3) (7.1) (5.7) (24.2)
(3.8) (5.4) (8.6) (4.6) (25.2))
(3.3) (5.8) (10.0) (8.2) (26.8))
LP, locking plate; NO, nonoperative; mos., months. Constant score: best possible ¼ 100 and worst possible ¼ 0. DASH score: 0 ¼ no disability and 100 ¼ most severe disability ) One missing value.
the final follow-up was 120 in the locking plate group compared to 111 in the nonoperative group (P ¼ .36), and the mean range of abduction was 114 vs 106 (P ¼ .28). The EQ-5Dindex score in the locking plate group before the fracture was 0.85 (SD 0.24); four months later it had decreased to 0.71 (SD 0.27). At 12 months the score was 0.74 (SD 0.24) and at 24 months 0.70 (SD 0.34) (Fig. 2). The values at all follow-ups were significantly lower than before the fracture (P ¼ .002, .003, and .006, respectively). In the nonoperative group the HRQoL (EQ-5D index score) decreased from 0.85 (SD 0.15) before the fracture to 0.61 (SD 0.23) at 4 months. At 12 months, the score was 0.65 (SD 0.28); at 24 months, 0.59 (SD 0.35) (Fig. 2). The values at all follow-ups were significantly lower than before the fracture (P < .001, < .001, and ¼ .001, respectively).
Discussion The results of the study indicate an advantage in functional outcome and quality of life in favor of the locking plate as compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus. However, despite a modern fixation technique and overall good primary reductions in the locking plate group, 13% of the patients had a severe complication requiring a major reoperation and 17% had a minor secondary surgical intervention. Regardless of the primary treatment, operative or nonoperative, this fracture resulted in a functional impairment of the shoulder and arm resulting in a substantial negative effect upon the patients’ HRQoL. The results for ROM, function, and HRQoL were all in favor of the locking plate group, and the differences of almost 9 points in the DASH score and 0.11 points in the EQ-5Dindex score are both considered to be clinically relevant differences; however, the study failed to confirm the statistical significance of these differences. As mentioned previously, factors complicating the power
analysis was that there was only 1 published RCT comparing nonoperative treatment with internal fixation,36 lacking outcome data after treatment with locking plates and lacking EQ-5D data in patients with proximal humeral fractures at the time when the study was planned (2002). A power analysis based on our present data indicates that a sample size of 160-180 patients would have been required to provide a power of 80% to identify a difference in the EQ-5Dindex score of 0.10 after 2 years with a significance level of 0.05. Although this lack of power in the comparison between the randomization groups is obviously a limitation of the study, in our opinion, it still provides valuable prospective data regarding the 2 treatment modalities, eg, data on HRQoL. Additionally, data from the study can be used in future meta-analyses. The negative effect on the HRQoL was considerable, regardless of the primary treatment. The deterioration in the EQ-5Dindex score group at 2 years in the locking plate fracture was 0.15, which is of the same magnitude as we have reported previously for patients with severely displaced 2-part fractures treated with a locking plate.30 For comparison, the deterioration in the EQ-5Dindex score in the nonoperative group was 0.26. The deterioration of the EQ5Dindex score in both groups was substantial and of the same magnitude as that reported for patients with unstable trochanteric and subtrochanteric fractures.13,27 This confirms our previous report30 that a displaced proximal humeral fracture in elderly patients has a major negative influence on the quality of life and underlines the need for further studies to improve the treatment. Furthermore, the EQ-5D data reported in this study can be used to construct QALYs, a measure frequently used in cost-effectiveness analyses. Our rate of 30% additional surgery in the locking plate group after 2 years, 13% major reoperations, and 17% minor is difficult to interpret, as there are few comparable prospective studies with a 2-year follow-up. When comparing with previous studies with a 1-year follow-up, it
RCT 3-part proximal humeral fractures
Figure 2 HRQoL according to the EQ-5D for all patients available at each follow-up (before fracture; n ¼ 59; 4 months, n ¼ 56; 12 months, n ¼ 54; and 24 months, n ¼ 53). 1 ¼ best possible score, 0 ¼ worst possible score. )1 missing value in each group.
is important to remember that after 1 year only 7% of our patients had been reoperated. The 7% 1-year reoperation rate compares favorably with the 19e28% previously reported rate in prospective studies, with a 1-year follow-up including a mixed population of 2-, 3-, and 4-part fractures.3,22,34 The fact that the majority of the reoperations were performed during the second year supports the recommendation that a 2-year follow-up should always be performed in studies on this type of fracture. Our results pertaining to functional outcome after 2 years in the locking plate group, DASH score 26, and Constant score 61 are comparable with those in previous prospective studies with at least 1-year follow-up. In these studies, the average DASH score varies from 15 to 21 points and the Constant score from 62 to 74.3,22,34 However, the comparison is difficult to interpret, because all of these studies included a mixed population of 2-, 3-, and 4-part fractures and also younger patients. The comparison with the Constant score is even more difficult, as this score is highly age-dependent. There has also been a controversy concerning how to assess strength in patients who are unable to achieve 90 of abduction. We opted to follow the recommendations of Constant;8 ie, patients who were unable to achieve the test position of 90 were assigned a strength score of 0. This may lead to in an underestimation of our results for the Constant score compared to previous studies. All but 1 of the fractures in the nonoperative group healed, but the majority of them were malunited. Only 14% of the fractures healed in a position that satisfied the criteria for a good reduction.22 Nevertheless, the ROM was surprisingly good, with a mean forward flexion of 111 and a mean abduction of 106 . A limited number of papers have
753 reported 2-year outcomes after nonoperative treatment. Zyto et al35 reported a mean forward flexion of 120 and a mean abduction of 100 after 10 years in 9 patients with 3-part fractures treated nonoperatively. The mean Constant score was 59. Hanson et al21 reported a Constant score of 74 after 1 year in a study of 160 patients. However, only 16% of the fractures were classified as 3- or 4-part fractures, and only patients considered suitable for primary nonoperative management were included. This population is probably not comparable to our study population. Despite the angular stability of the screws and our effort to maximize the number (mean 7) and length of the screws in the head fragment, there were signs of initial instability. This was reflected by a redisplacement into varus in 23% of the patients, 6% of whom also had an increased dorsal angulation, all occurring during the first 4 months. This is lower than what we reported in our study on severely displaced 2-part fractures in elderly patients treated with a locking plate,30 but again reflects the problem of fixation in the osteoporotic bone. The redisplacement was limited in the majority of the patients but resulted in secondary screw penetration in 3 of them. However, the secondary screw penetrations were minor and only contributed to a reoperation in 1 patient. Can we achieve better initial stability by this method? Possible factors contributing to instability are, for example, severe osteoporosis, insufficient numbers of screws in the head fragment, and malreduction. We cannot influence the degree of osteoporosis at the time of injury. The mean DXA total body T score in our patients was 1.4 and 25% satisfied the criteria for osteoporosis. But we can influence our surgical technique. We now almost always use the maximum number of screws in the head fragment in elderly patients in order to increase stability. Furthermore, after Gardner et al17 pointed out the importance of achieving an intact medial support to prevent postoperative varus redisplacement, we have paid extra attention to this aspect of the reduction. There is also a new plate design utilizing smooth angular-stable pegs with a steeper angle in order to improve fixation, theoretically reducing the risk of penetration of the head and preventing subacromial impingement.18 However, the possible advantage of this implant has not been tested in prospective comparative studies. A relatively high incidence of primary screw penetrations has been reported after fixation with locking plates. Our finding of 17% was comparable with the 12e14% reported in previous studies.3,5,30 However, the screw penetrations were slight (1e2 mm) and eccentric in the majority of the patients and did not constitute an indication for secondary surgical intervention in any case. When we started to use the locking plate we intended to maximize purchase in the osteoporotic bone by using as long screws as possible. Despite control with an X-ray image intensifier, avoiding minor screw penetration seems to be a difficult part of the surgical procedure. We are now more aware of this problem and, therefore, try to be even more observant
754 and aim at placing the screws 2e3 mm from the subchondral bone. However, it always comes down to finding a balance between a maximum possible fixation and the risk of secondary screw penetration due to secondary displacement. Three patients (10%) in the locking plate group displayed signs of AVN, 2 minor and 1 severe, compared to 2 patients (7%) in the nonoperative group, both minor. These figures are similar with what has previously been reported in the literature.21,29 Two of our patients with AVN required additional surgery, both in the locking plate group. One patient with major AVN was reoperated with a hemiarthroplasty and 1 patient with minor AVN underwent extraction of the plate and release of adhesions. The strength of our study is the prospective design including a well-defined study population with a defined type of fracture that is diagnosable on conventional radiographs in combination with CT. The patients were treated with a modern locking plate, and the quality of the surgery was what can be expected from orthopaedic surgeons experienced in shoulder surgery. The outcome was assessed with well-validated outcome instruments, including a selfreported quality-of-life instrument, and the follow-up rate was good. Furthermore, the final outcome was assessed by an unbiased observer, ie, an orthopaedic surgeon not previously involved in the treatment. The problem of lacking power in the comparison of the randomization groups is a limitation, as previously discussed. Moreover, the fact that our interpretation of the quality of life data is based on our patients’ ability to correctly recall their health status prior to the shoulder fracture may be considered a weakness. However, since a prospective collection of preinjury HRQoL data are not possible in trauma studies, we have to rely on preinjury recall or a comparison with population figures. Our patients’ assessment of their prefracture EQ-5Dindex score was slightly higher than in comparable age groups of the Swedish reference population,4 which may be explained by our inclusion criteria that selected healthier elderly individuals. Furthermore, a recent study reports that older patients can accurately recall their previous health status up to 6 weeks.26 Therefore, we believe that the effect of recall bias can be considered to be limited.
Conclusion In summary, the results of the study indicate an advantage in functional outcome and quality of life in favor of the locking plate, as compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus. The main advantage appeared to be an improved ROM. However, despite a modern fixation technique and overall good primary reductions in the locking plate group, 13% of the patients had a severe
P. Olerud et al. complication requiring a major reoperation and 17% had a minor secondary surgical intervention. The possible gain in function and HRQoL after treatment with a locking plate, balanced against the risk and inconvenience of surgery, is probably justified in the healthy elderly patient with high functional demands and when surgery is performed by an experienced surgeon. On the other hand, the overall acceptable outcome and limited need for secondary surgical interventions in the nonoperative group indicate that conservative treatment is probably sufficient for the most elderly patients with lower functional demands or when a surgeon with adequate experience is not available.
Disclaimer The authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.
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RCT 3-part proximal humeral fractures 11. Court-Brown CM, Garg A, McQueen MM. The epidemiology of proximal humeral fractures. Acta Orthop Scand 2001;72:365-71. 12. Dolan P, Gudex C, Kind P, Williams A. The time trade-off method: results from a general population study. Health Econ 1996;5:141-54. 13. Ekstr€ om W, Nemeth G, Samneg ard E, Dalen N, Tidermark J. Quality of life after a subtrochanteric fracture: a prospective cohort study on 87 elderly patients. Injury 2009;40:371-6. doi:10.1016/j.injury.2008.09.010 14. Fankhauser F, Boldin C, Schippinger G, Haunschmid C, Szyszkowitz R. A new locking plate for unstable fractures of the proximal humerus. Clin Orthop Relat Res 2005:176-81. doi:10.1097/ 01.blo.0000137554.91189.a9 15. Fjalestad T, Hole MO, Jorgensen JJ, Stromsoe K, Kristiansen IS. Health and cost consequences of surgical versus conservative treatment for a comminuted proximal humeral fracture in elderly patients. Injury 2009;41:599-605. doi:10.1016/j.injury.2009.10.056 16. Gaebler C, McQueen MM, Court-Brown CM. Minimally displaced proximal humeral fractures: epidemiology and outcome in 507 cases. Acta Orthop Scand 2003;74:580-5. doi:10.1080/00016470310017992 17. Gardner MJ, Weil Y, Barker JU, Kelly BT, Helfet DL, Lorich DG. The importance of medial support in locked plating of proximal humerus fractures. J Orthop Trauma 2007;21:185-91. doi:10.1097/BOT. 0b013e3180333094 18. Gille J, Schulz AP, Queitsch C, Paech A, Jurgens C. Initial results of the s3-humerus plate. Open Orthop J 2008;2:133-6. doi:10.2174/ 1874325000802010133 19. Handoll HH, Gibson JN, Madhok R. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev 2003: CD000434. doi:10.1002/14651858.CD000434 20. Handschin AE, Cardell M, Contaldo C, Trentz O, Wanner GA. Functional results of angular-stable plate fixation in displaced proximal humeral fractures. Injury 2008;39:306-13. doi:10.1016/j.injury. 2007.10.011 21. Hanson B, Neidenbach P, de Boer P, Stengel D. Functional outcomes after nonoperative management of fractures of the proximal humerus. J Shoulder Elbow Surg 2009;18:612-21. doi:10.1016/j.jse.2009.03.024 22. Hirschmann MT, Quarz V, Audige L, Ludin D, Messmer P, Regazzoni P, et al. Internal fixation of unstable proximal humerus fractures with an anatomically preshaped interlocking plate: a clinical and radiologic evaluation. J Trauma 2007;63:1314-23. doi:10.1097/01. ta.0000240457.64628.38 23. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm,
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shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med 1996;29:602-8. Kanis JA, Melton LJ III, Christiansen C, Johnston CC, Khaltaev N. The diagnosis of osteoporosis. J Bone Miner Res 1994;9:1137-41. Katz S, Ford AB, Moskowitz RW, Jackson BA, Jaffe MW. Studies of illness in the aged. The index of Adl: A standardized measure of biological and psychosocial function. JAMA 1963;185:914-9. Marsh J, Bryant D, MacDonald SJ. Older patients can accurately recall their preoperative health status six weeks following total hip arthroplasty. J Bone Joint Surg Am 2009;91:2827-37. doi:10.2106/JBJS.H. 01415 Miedel R, Ponzer S, T€ornkvist H, S€oderqvist A, Tidermark J. The standard Gamma nail or the Medoff sliding plate for unstable trochanteric and subtrochanteric fractures. A randomized, controlled trial. J Bone Joint Surg Br 2005;87:68-75. doi:10.1302/0301-620X.87B1.15295 Neer CS II. Displaced proximal humeral fractures. I. Classification and evaluation. J Bone Joint Surg Am 1970;52:1077-89. Neer CS II. Displaced proximal humeral fractures. II. Treatment of three-part and four-part displacement. J Bone Joint Surg Am 1970;52: 1090-103. Olerud P, Ahrengart L, S€oderqvist A, Saving J, Tidermark J. Quality of life and functional outcome after a 2-part proximal humeral fracture: A prospective cohort study on 50 patients treated with a locking plate. J Shoulder Elbow Surg 2010;19:814-22. doi:10.1016/j.jse.2009.11.046 Owens WD, Felts JA, Spitznagel EL Jr. ASA physical status classifications: a study of consistency of ratings. Anesthesiology 1978;49: 239-43. Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc 1975;23:433-41. Resch H, Beck E, Bayley I. Reconstruction of the valgus-impacted humeral head fracture. J Shoulder Elbow Surg 1995;4:73-80. Sudkamp N, Bayer J, Hepp P, Voigt C, Oestern H, Kaab M, et al. Open reduction and internal fixation of proximal humeral fractures with use of the locking proximal humerus plate. Results of a prospective, multicenter, observational study. J Bone Joint Surg Am 2009;91:13208. doi:10.2106/JBJS.H.00006 Zyto K. Non-operative treatment of comminuted fractures of the proximal humerus in elderly patients. Injury 1998;29:349-52. Zyto K, Ahrengart L, Sperber A, T€ornkvist H. Treatment of displaced proximal humeral fractures in elderly patients. J Bone Joint Surg Br 1997;79:412-7.
www.elsevier.com/locate/ymse
SHOULDER
Internal fixation versus nonoperative treatment of displaced 3-part proximal humeral fractures in elderly patients: a randomized controlled trial Per Olerud, MDa,*, Leif Ahrengart, MD, PhDa, Sari Ponzer, MD, PhDa, Jenny Saving, MDa, Jan Tidermark, MD, PhDa,b a
Karolinska Institutet, Department of Clinical Science and Education, Section of Orthopaedics, Stockholm S€oder Hospital, Sweden b Department of Orthopaedics, Capio S:t G€ orans Hospital, Stockholm, Sweden Background: The aim of the study was to report the 2-year outcome after a displaced 3-part fracture of the proximal humerus in elderly patients randomized to treatment with a locking plate or nonoperative treatment. Patients and methods: We included 60 patients, mean age 74 years (range, 56-92), 81% being women. The main outcome measures were the Constant and Disabilities of the Arm, Shoulder and Hand (DASH) scores and the health-related quality of life (HRQoL) according to the EQ-5D. Results: At the final 2-year follow-up, the results for range of motion (ROM), function and HRQoL were all in favor of the locking plate group. The mean flexion in the locking plate group was 120 compared to 111 in the nonoperative group (P ¼ .36) and the mean abduction was 114 compared to 106 (P ¼ .28). The corresponding values for the Constant score were 61 versus 58 (P ¼ .64), for DASH 26 versus 35 (P ¼ .19), and the mean EQ-5D index score was 0.70 compared to 0.59 (P ¼ .26). In spite of good primary reduction in 86% of the fractures in the locking plate group, 13% of the patients had a fracture complication requiring a major reoperation and 17% had a minor reoperation. Conclusion: The results of our study indicate an advantage in functional outcome and HRQoL in favor of the locking plate compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus, but at the cost of additional surgery in 30% of the patients. Level of evidence: Level I, Randomized Controlled Trial, Treatment Study. Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. Keywords: Proximal humeral fractures; internal fixation; elderly; functional outcome; quality of life
The study was supported in part by grants from the Trygg-Hansa Insurance Company and the Stockholm County Council. The study was approved by the Local Ethics Committee in Huddinge, Stockholm, Sweden (number 342/02). The study was conducted according to the principles of the Helsinki Declaration. All patients gave their informed consent to participate in the
study and the protocol was approved by the Local Ethics Committee in Huddinge, Stockholm, Sweden (number 342/02). *Reprint requests: Per Olerud, MD, Department of Orthopaedics, Stockholm S€oder Hospital, S - 118 83 Stockholm, Sweden. E-mail address: [email protected] (P. Olerud).
1058-2746/$ - see front matter Ó 2011 Journal of Shoulder and Elbow Surgery Board of Trustees. doi:10.1016/j.jse.2010.12.018
748 The proximal humeral fracture is the third most common fracture in elderly patients after fractures in the hip and distal radius1 and it is strongly associated with osteoporosis. The vast majority of the fractures are undisplaced or minimally displaced11 and can be treated nonoperatively.16 The most frequently used classification for proximal humeral fractures is the Neer classification.28,29 This classification is based on the 4 anatomical segments of the proximal humerusdthe humeral head, shaft, and the greater and lesser tuberclesdand whether these segments are fractured and displaced. The surgical neck 3-part fracture is defined as a fracture with at least 10 mm of displacement and/or 45 of angulation between the head and shaft fragments and a fracture of the greater or lesser tubercle with at least 10 mm of displacement. The 3-part proximal humeral fracture accounts for approximately 10% of all proximal humeral fractures.11 Operative treatment of displaced 3-part fractures in younger patients is not controversial. The main controversy pertains to elderly patients with varying degrees of osteoporosis and displaced fractures sustained after low-energy trauma. In this patient group, there is little evidence and poor consensus regarding the optimal treatment modality.19 The availability of modern orthopaedic implants such as locking plates with improved purchase in osteoporotic bone has contributed to a trend towards more frequent surgical interventions. Open reduction and internal fixation with locking plates have the potential to restore the anatomy in an excellent manner; but, there is a risk of complications related to both the implant3,14,20,22 and the surgery itself.6,30 Conservative treatment with short immobilization and early physiotherapy is a noninvasive, simple, and safe option, and acceptable results after nonoperative treatment have been reported.11,21,35 To the best of our knowledge, there are only 2 previous randomized controlled trials (RCTs) comparing internal fixation with nonoperative treatment in patients with proximal humeral fractures. The first study was done by Zyto et al, who in 1997 reported the outcome of nonoperative treatment compared with tension band wiring in 40 patients with displaced 3- and 4-part fractures.36 The second was a recently published study by Fjalestad et al,15 including 50 patients with displaced 3- and 4-part fractures comparing nonoperative treatment with a locking plate with a 12-month follow-up. However, the single paper from this trial published so far is focused on quality-adjusted life years (QALYs) and societal costs. No differences regarding these aspects were reported. The latest Cochrane review (systematic review of randomized controlled trials [RCTs]) regarding this topic19 concludes that there is insufficient evidence from RCTs to determine which interventions are the most appropriate for the different types of proximal humeral fractures. The limited evidence available does not confirm that surgery is preferable to conservative treatment, and complications associated with surgery need to be considered. Consequently,
P. Olerud et al. there is a need for future RCTs to more clearly define the role and type of surgical intervention. The aim of this study was to report the outcome after a displaced 3-part fracture of the proximal humerus in elderly patients allocated to treatment with a locking plate or nonoperative treatment in an RCT with a 2-year followup. The primary aim was to report the health-related quality of life (HRQoL) according to EQ-5Dä (EuroQol Group, Rotterdam, the Netherlands), while our secondary aims were to report the functional outcome according to the Constant and DASH scores.
Patients and methods Patients In an RCT with a 2-year follow-up, we included 60 patients with an acute displaced 3-part fracture of the surgical neck of the humerus, according to the classification of Neer,28,29 allocated to treatment with open reduction and internal fixation with a locking plate or nonoperative treatment between April 2003 and March 2008. The fracture inclusion criteria, based on conventional radiographs and computer tomography, were a displacement of the shaft of more than 10 mm and/or >45 of angulation in relation to the head fragment, combined with a displacement of the greater or lesser tubercle of more than 10 mm in relation to the head fragment. A minimally displaced/undisplaced fracture of the other tubercle, such as not meeting the criteria to be considered a separate fracture segment according to Neer, was not considered to be an exclusion criterion. Patients with a completely displaced shaft in relation to the head fragment, such as a fracture without bony contact, were considered to present an absolute indication for surgery and, therefore, were not included, nor were patients with a valgus impact fracture.10,33 The patient inclusion criteria were age 55 or older, a fracture sustained after a low-energy trauma (ie, simple fall), no previous shoulder problems, independent living conditions (ie, not institutionalized), and no severe cognitive dysfunction (ie, 3 correct answers on a 10-item Short Portable Mental Status Questionnaire [SPMSQ]).32 After clearance by an anesthetist, the patients were randomized (independently prepared opaque, sealed envelopes) to open reduction and internal fixation with a locking plate or nonoperative treatment.
Surgical intervention and nonoperative treatment All operations in patients randomized to surgery were performed by 1 of 2 orthopaedic surgeons, both well experienced in shoulder surgery, and the operations were performed within a mean of 6 (SD 4.1) days after the injury. All patients were given 2 g cloxacillin (Ekvacillinâ; AstraZeneca, S€ odert€alje, Sweden) preoperatively. The Philosâ plate (Synthes, Stockholm, Sweden) was used in all patients. This plate is anatomically shaped and is recommended to be placed at least 8 mm distal to the upper end of the greater tubercle (rotator cuff insertion) and slightly dorsal to the long head of biceps. It allows for 9 locking screws in the proximal fragment and is available in different lengths, allowing either locked or nonlocked screws in the shaft. The surgery was
RCT 3-part proximal humeral fractures performed in a modified beach-chair position utilizing a deltopectoral approach. Fractures of the lesser and/or greater tubercle with displacement and/or instability were fixed with nonabsorbable sutures. The reduction and position of the implant was checked with the aid of an X-ray image intensifier. The duration of surgery was recorded. The head/shaft angle, dorsal/ventral angle, and distance between the superior border of the greater tubercle and vertex of the head were measured postoperatively.22 Additionally, the position and utilization of the plate was recorded, such as the distance from the top of the greater tubercle, length of the plate (3 or 5 holes), number of screws in the head fragment, and if there was any screw penetrating the humeral head. After surgery, the arm was placed in a sling and all patients were referred to a physiotherapist. The sling was used for 4 weeks; afterwards, the patients were allowed to use it at their own convenience. Pendulum exercises and passive elevation/abduction up to 90 were started from the first postoperative day. After 4 weeks, the patients were allowed a free active range of motion (ROM). The fracture reduction and implant position were assessed using the postoperative radiographs. Nonoperatively treated patients had their arm immobilized in a sling for 2 weeks, after which time they were allowed to use it at their own convenience. After 2 weeks, the patients were referred to a physiotherapist, and pendulum exercises and passive elevation/abduction up to 90 were started. After 4 weeks, they were allowed a free active ROM.
Primary assessment and follow-up Besides classification of the fracture type according to Neer, as described above, assessments of cognitive function according to the SPMSQ32 and of general health according to the ASA classification31 were performed. Moreover, the patients were interviewed about their living conditions and their activities of daily living (ADL) status,25 and were also asked to rate their HRQoL according to the EQ-5D2 during the last week before the fracture as baseline (recall). Height and weight were measured, and body mass index (kg/m2) was calculated. Bone mineral density (BMD) was measured by dual-emission X-ray absorptiometry (DXA) with a Lunarâ densitometer (Lunar, Madison, WI). The patients were summoned at 4 months (mean 4.2, SD 0.8), 12 months (mean 12.3, SD 0.7), and 24 months (mean 25.3, SD 2.8). The final 24-month follow-up was performed by an independent orthopaedic surgeon not previously involved in the treatment. In the outcome analyses, all patients remained in their randomization group regardless of secondary procedures according to the intention-to-treat principle. Each follow-up included an X-ray check-up with a standardized frontal and lateral projection. In the locking plate group, we assessed fracture healing and redisplacement with changes in the head/shaft angle and dorsal/ventral angle. Furthermore, any additional screws penetrating the head or loosening of the plate were recorded. In the nonoperative group, we assessed fracture healing, including the position in which the fracture finally healed (ie, head/shaft angle, dorsal/ventral angle), and the distance between the superior border of the greater tubercle and vertex of the head.22 In both groups, any signs of avascular necrosis (AVN) and post-traumatic osteoarthritis (OA) were recorded. Additional operations after primary treatment, including the indication and date of the operation, were recorded. The
749 functional outcome was assessed using the Constant8,9 and DASH scores,23 while HRQoL was assessed using the EQ-5D.12
Methods Pain was assessed on a visual analogue scale (Visual Analog Scale [VAS] scores, 0e100: 0 ¼ no pain; 100 ¼ worst possible pain). The Constant score8,9 is a widely used system for measuring shoulder function regardless of the diagnosis. The normal population values depend on age, gender, and activity level of the patient.7 The best possible score is 100 and includes an assessment of shoulder function in 4 dimensions: pain (15), activities of daily living (ADL) (20), ROM (40), and strength (25). In the strength assessment, we followed the recommendations of Constant et al8; ie, patients who were unable to achieve the test position of 90 were assigned a strength score of 0. The DASH23 questionnaire is a region-specific outcome instrument developed to measure upper extremity disability and symptoms. The main part, the 30-item disability/symptom scale, was used in this study. The scores from each of the items are used to calculate a scale score (DASH score) ranging from 0 (no disability) to 100 (most severe disability). The HRQoL was rated using the EQ-5D.2 The EQ-5D has 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is divided into 3 of severity: no problem, some problems, and major problems. An EQ-5D index score of 0 indicated the worst possible state of health and a score of 1 the best possible.
Sample size At the time when the study was planned (2002) there was only 1 published RCT comparing nonoperative treatment with internal fixation.36 Moreover, there were not yet any published papers reporting the outcome after treatment with locking plates. Finally, there were no available data for the primary outcome measure used in this study (ie, the EQ-5D) in patients with proximal humeral fractures. Therefore, we did not have any reliable data allowing us to perform a formal power analysis, but we made an estimation of power based on assumptions. The estimation indicated that a sample size of 60 patients would be sufficient.
Statistical analysis The statistical software used was SPSS 18.0 for Windows (IBM Corporation, Somers, NY). Scale variables and ordinal variables were tested using the Mann-Whitney U test. The Wilcoxon signed-ranks test was used to compare the EQ-5D between before fracture and at follow-ups. Nominal variables were tested using the chi-square or Fisher’s exact test. All tests were 2-sided. The results were considered significant at P < .05. In order to maximize the power of the statistical tests, we did not apply any correction factor to the P values (eg, Bonferroni correction), which may increase the possibility of a type I error.
Results A flow chart for all patients included is shown in Figure 1. One patient in the nonoperative group opted to be excluded
750
P. Olerud et al. Included patients 60
Randomized to LP 30 Operated with LP 29 Operated with HA 1 Deceased 2 Lost to f-u 1 Available at 4 mth f-u 27
Deceased (cum) 2 Lost to f-u 1 Available at 12 mth f-u 27
Deceased (cum) 2 Lost to f-u 1
Available at 24 mth f-u 27
Randomized to NO 30 Treated non-operatively 29 Opted to be excluded 1 Deceased 0 Lost to f-u 0 Available at 4 mth f-u 29
Deceased (cum) 1 Lost to f-u 1 Available at 12 mth f-u 27
Deceased (cum) 2 Lost to f-u 1
Available at 24 mth f-u 26
Figure 1 Flowchart for all patients included (n ¼ 60). LP, locking plate; NO, nonoperative; HA, hemiarthroplasty.
from the study after randomization and 1 patient in the locking plate group was treated with a primary hemiarthroplasty (HA). According to the radiological examinations, this patient had a 3-part fracture with a displaced greater tubercle and a minimally displaced lesser tubercle (2 mm), but at surgery a displacement of both tubercles exceeding 10 mm was diagnosed; ie, it was a true 4-part fracture according to the Neer classification. This patient died after 2.5 months due to causes not related to surgery. The overall mortality rate at 24 months was 7% (4 out of 59): 2 out of 30 in the locking plate group and 2 out of 29 in the nonoperative group. One patient in each group was lost to the final follow-up (Fig. 1). Baseline data for all patients included in relation to randomization group (n ¼ 59) are displayed in Table I. The mean age for all patients was 73.9 years and 81% of them were females. The mean age was 75.1 years for women and 68.7 years for men. The injured shoulder was in the nondominant arm in 35 patients (59%). The mean EQ-5D index score before fracture was 0.85 and the vast majority of the patients, 98%, were assessed as ADL A or B; ie, they were either independent in all 6 functions of ADL or independent in all but 1. According to the inclusion criteria, there were no patients with severe cognitive dysfunction (SPMSQ < 3) and all patients came from independent living conditions. The mean DXA total body T-score was 1.4 and 15 out of 59 patients (25%) had a T-score of more than 2.5 SD below the mean for young adults, and, consequently, satisfied the criteria for osteoporosis
according to the WHO definition.24 The vast majority of the fractures, 58 out of 59 (98%), were 3-part fractures with a displaced greater tubercle. Twenty-five (43%) of these fractures had an associated undisplaced or minimally displaced lesser tubercle. The lesser tubercle was undisplaced in 9 patients and displaced 1 mm in 5, 2 mm in 4, 3 mm in 4, and 5 mm in 3 patients. The single 3-part fracture with a displaced lesser tubercle had no fracture of the greater tubercle.
Clinical and radiological outcome In the locking plate group, the mean duration of surgery was 97 minutes (range, 52e181). The assessment of the postoperative fracture reduction showed a mean head/shaft angle (frontal projection) of 129 (range, 106e150 ), a mean dorsal/ventral angle (lateral projection) of 9 (10 e30 ), and a mean distance between the greater tubercle and the vertex of the head of 3 mm (5e15). A good reduction22 (ie, a head/shaft angle of 135 20 and a dorsal/ventral angle of 0 25 ) was achieved in 25 patients (86%). The plate was positioned at a mean of 7 mm (4e22) below the top of the greater tubercle, and a 3-hole plate was utilized in 26 patients and a 5-hole one in the remaining 3. The mean number of screws in the head fragment was 7 (4e8). A screw penetration of the head was found on the postoperative radiograph in 5 patients (17%). The penetration was 1 mm in 3 patients, 2 mm in 1, and 3 mm in 1. The fracture position was unchanged in 20 of the 26 patients (77%) available at 4 months and not reoperated. In 6 patients (23%), the head/shaft angle had decreased by a mean of 10 (range, 3e23 ). Additionally, in 4 of these 6 patients, there was also a mean increase in dorsal angulation of 13 (range, 2e28 ). Additional screw penetration of the head had occurred at 4 months in 3 of the 26 patients (12%) at risk. All secondary screw penetrations occurred in patients with a changed fracture position. There was a secondary displacement of the greater tubercle before the 4-month follow-up in 4 of the 25 patients (16%) at risk with a mean of 18 mm (range, 2e30). The single 3-part fracture with a displaced lesser tubercle showed no detectable secondary displacement. There were no additional changes in fracture position and no additional screw penetrations in any of the patients after the 4-month follow-up. Three patients (10%) in the locking plate group displayed signs of AVN: 2 minor and 1 severe, 2 of whom were reoperated. In the locking plate group, 9 patients (30%) had additional surgery during the 2-year follow-up period (Table II). Four patients (13%) required major additional surgery: 1 due to a primary infection; 1 due to haematogenous infection; 1 due to nonunion; and 1 due to severe AVN. Five patients (17%) had minor additional surgery, all during the second year, with removal of the plate and release of adhesions. The indication for surgery was secondary screw penetration in 1 patient, postoperative
RCT 3-part proximal humeral fractures Table I
751
Baseline data for all patients included in relation to randomisation group (n ¼ 59)
Mean (range) age in years Gender, female, n (%) Mean (range) cognitive function Mean (range) EQ-5Dindex score prefracture ADL A and B, n (%) Nondominant arm, n (%) Mean BMI (kg/m2) Mean (SD) DXA total body T score Fx type 3-part with displaced GT 3-part with displaced LT
Locking plate n ¼ 30
Nonoperative n ¼ 29
P
72.9 24 9.4 0.85 29 19 26.6 1.3
74.9 24 9.2 0.85 29 16 25.9 1.4
.26 .79 .25 .35 1.0 .52 .59 .92 1.0
(56-92) (80) (5-10) (0.19-1.0) (97) (63) (19-37) (4.1-1.3)
29 (97) 1 (3)
(58-88) (83) (6-10) (0.41-1.0) (100) (55) (14-39) (4.3-1.6)
29 (100) 0 (0)
ADL, activities of daily living; DXA, dual-emission X-ray absorptiometry; Fx, fracture; GT, greater tubercle; LT, lesser tubercle.
stiffness in 2, and impingement in 2. All but 1 of these patients had improved function according to DASH between the 12- and 24-month follow-up with a mean of 6.2 points (range, 0e15.8). One patient in the nonoperative group had a nonunion. The other 28 fractures healed with a mean head/shaft angle (frontal projection) of 121 (range, 87e193 ), a mean dorsal/ ventral angle (lateral projection) of 48 (6e117 ) and a mean distance between the greater tubercle and the vertex of the head of 0 mm (8e20). Only 4 of the fractures (14%) healed in a position that satisfied the criteria for a good reduction.22 The patient with a nonunion opted to abstain from surgical intervention. A contributing factor to this decision was a late diagnosis of axillary nerve palsy. One patient (3%) had additional minor surgery during the 2-year follow, an arthroscopic acromioplasty due to impingement
Table II
resulting from a malunited greater tubercle (Table II). Moreover, 2 patients (7%) displayed signs of minor AVN and 1 patient (3%) had post-traumatic osteoarthritis.
Functional outcome and HRQoL The functional outcomes according to the Constant and DASH scores are displayed in Table III and the HRQoL (EQ-5Dindex score) in Figure 2. The figures for the Constant and DASH scores, as well as the EQ-5Dindex score, were all in favor of the locking plate group on all follow-up occasions, although not reaching statistical significance. The mean pain score according to VAS at the final followup was 17 in the locking plate group compared to 20 in the nonoperative group (P ¼ .94). The mean range of flexion at
Data on the 10 patients undergoing additional surgery after primary treatment
Group
Gender/age
Fx type
T-score
Reduction
No. of screws
Indication
Reoperation/reoperations
LP
M/58
3-GT
1.5
140 /12
8
Deep infection
LP
F/74
3-GT
4.1
115 /12
5
Nonunion
LP
F/67
3-GT
0
111 /3
8
Deep infection
NO LP LP
M/73 M/66 F/59
3-GT 3-GT 3-GT
0.6 2.3 1.2
NA 150 /6 123 /1
NA 6 8
LP LP LP LP
F/56 F/66 F/82 F /77
3-GT 3-GT 3-GT 3-GT
2.4 0.3 0.7 2.6
129 /3 131 /-10 130 /30 140 /10
7 8 8 7
Impingement Impingement Stiffness, sec. screw penetration Stiffness Stiffness AVN, minor AVN, severe
Wound revision, repeated lavage, extraction of plate and spacer Reosteosynthesis, LP þ autologous bone transplant Wound revision þ extraction of plate, healed fx Arthroscopic acromioplasty Extraction of plate, release Extraction of plate, release Extraction of plate, release Extraction of plate, release Extraction of plate, release Extraction of plate and hemiarthroplasty
Time
DASH 24 mos.
3.7
47.5
10.0
80.8
12.9
64.2
13.4 14.7 18.1
39.2 5.0 0.0
20.0 23.1 23.4 24.8
0.0 25.0 24.2 Missing
LP, locking plate; NO, nonoperative; M, male; F, female; Fx, fracture; GT, greater tubercle; Reduction, valgus angle/dorsal angle; No. of screws, no of head screws; Time, time elapsed from the primary operation or the start of nonoperative treatment in months; NA, not applicable; mos., months; AVN, avascular necrosis.
752
P. Olerud et al.
Table III The Constant and DASH scores (mean; SD) for all patients available at each follow-up (4 mos, n ¼ 56; 12 mos., n ¼ 54; 24 mos, n ¼ 53) 4 mos. LP Constant score (0e100) I. Pain (0e15) II. ADL (0e20) III. ROM (0e40) IV. Strength (0e25) DASH (100e0)
NO
52.3 (14.3)) 10.0 13.8 22.2 6.3 36.2
12 mos.
(3.6)) (4.0)) (6.4)) (4.3)) (22.4))
24 mos.
P
LP
NO
P
LP
NO
P
48.8 (16.3)
.48
61.5 (18.4))
56.8 (16.8)
.18
61.0 (19.2)
58.4 (23.1)
.64
9.5 12.8 20.6 6.0 35.7
.48 .42 .61 .64 .85
11.9 14.9 27.0 7.6 29.1
10.6 14.2 24.1 8.0 35.1
.15 .52 .11 .97 .32
12.4 14.1 27.3 7.3 26.4
11.2 14.6 24.7 7.9 35.0
.12 .75 .41 .88 .19
(3.4) (4.9) (8.2) (4.3) (20.1))
(3.2)) (5.0)) (8.7)) (4.7)) (23.3)
(3.5) (5.3) (7.1) (5.7) (24.2)
(3.8) (5.4) (8.6) (4.6) (25.2))
(3.3) (5.8) (10.0) (8.2) (26.8))
LP, locking plate; NO, nonoperative; mos., months. Constant score: best possible ¼ 100 and worst possible ¼ 0. DASH score: 0 ¼ no disability and 100 ¼ most severe disability ) One missing value.
the final follow-up was 120 in the locking plate group compared to 111 in the nonoperative group (P ¼ .36), and the mean range of abduction was 114 vs 106 (P ¼ .28). The EQ-5Dindex score in the locking plate group before the fracture was 0.85 (SD 0.24); four months later it had decreased to 0.71 (SD 0.27). At 12 months the score was 0.74 (SD 0.24) and at 24 months 0.70 (SD 0.34) (Fig. 2). The values at all follow-ups were significantly lower than before the fracture (P ¼ .002, .003, and .006, respectively). In the nonoperative group the HRQoL (EQ-5D index score) decreased from 0.85 (SD 0.15) before the fracture to 0.61 (SD 0.23) at 4 months. At 12 months, the score was 0.65 (SD 0.28); at 24 months, 0.59 (SD 0.35) (Fig. 2). The values at all follow-ups were significantly lower than before the fracture (P < .001, < .001, and ¼ .001, respectively).
Discussion The results of the study indicate an advantage in functional outcome and quality of life in favor of the locking plate as compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus. However, despite a modern fixation technique and overall good primary reductions in the locking plate group, 13% of the patients had a severe complication requiring a major reoperation and 17% had a minor secondary surgical intervention. Regardless of the primary treatment, operative or nonoperative, this fracture resulted in a functional impairment of the shoulder and arm resulting in a substantial negative effect upon the patients’ HRQoL. The results for ROM, function, and HRQoL were all in favor of the locking plate group, and the differences of almost 9 points in the DASH score and 0.11 points in the EQ-5Dindex score are both considered to be clinically relevant differences; however, the study failed to confirm the statistical significance of these differences. As mentioned previously, factors complicating the power
analysis was that there was only 1 published RCT comparing nonoperative treatment with internal fixation,36 lacking outcome data after treatment with locking plates and lacking EQ-5D data in patients with proximal humeral fractures at the time when the study was planned (2002). A power analysis based on our present data indicates that a sample size of 160-180 patients would have been required to provide a power of 80% to identify a difference in the EQ-5Dindex score of 0.10 after 2 years with a significance level of 0.05. Although this lack of power in the comparison between the randomization groups is obviously a limitation of the study, in our opinion, it still provides valuable prospective data regarding the 2 treatment modalities, eg, data on HRQoL. Additionally, data from the study can be used in future meta-analyses. The negative effect on the HRQoL was considerable, regardless of the primary treatment. The deterioration in the EQ-5Dindex score group at 2 years in the locking plate fracture was 0.15, which is of the same magnitude as we have reported previously for patients with severely displaced 2-part fractures treated with a locking plate.30 For comparison, the deterioration in the EQ-5Dindex score in the nonoperative group was 0.26. The deterioration of the EQ5Dindex score in both groups was substantial and of the same magnitude as that reported for patients with unstable trochanteric and subtrochanteric fractures.13,27 This confirms our previous report30 that a displaced proximal humeral fracture in elderly patients has a major negative influence on the quality of life and underlines the need for further studies to improve the treatment. Furthermore, the EQ-5D data reported in this study can be used to construct QALYs, a measure frequently used in cost-effectiveness analyses. Our rate of 30% additional surgery in the locking plate group after 2 years, 13% major reoperations, and 17% minor is difficult to interpret, as there are few comparable prospective studies with a 2-year follow-up. When comparing with previous studies with a 1-year follow-up, it
RCT 3-part proximal humeral fractures
Figure 2 HRQoL according to the EQ-5D for all patients available at each follow-up (before fracture; n ¼ 59; 4 months, n ¼ 56; 12 months, n ¼ 54; and 24 months, n ¼ 53). 1 ¼ best possible score, 0 ¼ worst possible score. )1 missing value in each group.
is important to remember that after 1 year only 7% of our patients had been reoperated. The 7% 1-year reoperation rate compares favorably with the 19e28% previously reported rate in prospective studies, with a 1-year follow-up including a mixed population of 2-, 3-, and 4-part fractures.3,22,34 The fact that the majority of the reoperations were performed during the second year supports the recommendation that a 2-year follow-up should always be performed in studies on this type of fracture. Our results pertaining to functional outcome after 2 years in the locking plate group, DASH score 26, and Constant score 61 are comparable with those in previous prospective studies with at least 1-year follow-up. In these studies, the average DASH score varies from 15 to 21 points and the Constant score from 62 to 74.3,22,34 However, the comparison is difficult to interpret, because all of these studies included a mixed population of 2-, 3-, and 4-part fractures and also younger patients. The comparison with the Constant score is even more difficult, as this score is highly age-dependent. There has also been a controversy concerning how to assess strength in patients who are unable to achieve 90 of abduction. We opted to follow the recommendations of Constant;8 ie, patients who were unable to achieve the test position of 90 were assigned a strength score of 0. This may lead to in an underestimation of our results for the Constant score compared to previous studies. All but 1 of the fractures in the nonoperative group healed, but the majority of them were malunited. Only 14% of the fractures healed in a position that satisfied the criteria for a good reduction.22 Nevertheless, the ROM was surprisingly good, with a mean forward flexion of 111 and a mean abduction of 106 . A limited number of papers have
753 reported 2-year outcomes after nonoperative treatment. Zyto et al35 reported a mean forward flexion of 120 and a mean abduction of 100 after 10 years in 9 patients with 3-part fractures treated nonoperatively. The mean Constant score was 59. Hanson et al21 reported a Constant score of 74 after 1 year in a study of 160 patients. However, only 16% of the fractures were classified as 3- or 4-part fractures, and only patients considered suitable for primary nonoperative management were included. This population is probably not comparable to our study population. Despite the angular stability of the screws and our effort to maximize the number (mean 7) and length of the screws in the head fragment, there were signs of initial instability. This was reflected by a redisplacement into varus in 23% of the patients, 6% of whom also had an increased dorsal angulation, all occurring during the first 4 months. This is lower than what we reported in our study on severely displaced 2-part fractures in elderly patients treated with a locking plate,30 but again reflects the problem of fixation in the osteoporotic bone. The redisplacement was limited in the majority of the patients but resulted in secondary screw penetration in 3 of them. However, the secondary screw penetrations were minor and only contributed to a reoperation in 1 patient. Can we achieve better initial stability by this method? Possible factors contributing to instability are, for example, severe osteoporosis, insufficient numbers of screws in the head fragment, and malreduction. We cannot influence the degree of osteoporosis at the time of injury. The mean DXA total body T score in our patients was 1.4 and 25% satisfied the criteria for osteoporosis. But we can influence our surgical technique. We now almost always use the maximum number of screws in the head fragment in elderly patients in order to increase stability. Furthermore, after Gardner et al17 pointed out the importance of achieving an intact medial support to prevent postoperative varus redisplacement, we have paid extra attention to this aspect of the reduction. There is also a new plate design utilizing smooth angular-stable pegs with a steeper angle in order to improve fixation, theoretically reducing the risk of penetration of the head and preventing subacromial impingement.18 However, the possible advantage of this implant has not been tested in prospective comparative studies. A relatively high incidence of primary screw penetrations has been reported after fixation with locking plates. Our finding of 17% was comparable with the 12e14% reported in previous studies.3,5,30 However, the screw penetrations were slight (1e2 mm) and eccentric in the majority of the patients and did not constitute an indication for secondary surgical intervention in any case. When we started to use the locking plate we intended to maximize purchase in the osteoporotic bone by using as long screws as possible. Despite control with an X-ray image intensifier, avoiding minor screw penetration seems to be a difficult part of the surgical procedure. We are now more aware of this problem and, therefore, try to be even more observant
754 and aim at placing the screws 2e3 mm from the subchondral bone. However, it always comes down to finding a balance between a maximum possible fixation and the risk of secondary screw penetration due to secondary displacement. Three patients (10%) in the locking plate group displayed signs of AVN, 2 minor and 1 severe, compared to 2 patients (7%) in the nonoperative group, both minor. These figures are similar with what has previously been reported in the literature.21,29 Two of our patients with AVN required additional surgery, both in the locking plate group. One patient with major AVN was reoperated with a hemiarthroplasty and 1 patient with minor AVN underwent extraction of the plate and release of adhesions. The strength of our study is the prospective design including a well-defined study population with a defined type of fracture that is diagnosable on conventional radiographs in combination with CT. The patients were treated with a modern locking plate, and the quality of the surgery was what can be expected from orthopaedic surgeons experienced in shoulder surgery. The outcome was assessed with well-validated outcome instruments, including a selfreported quality-of-life instrument, and the follow-up rate was good. Furthermore, the final outcome was assessed by an unbiased observer, ie, an orthopaedic surgeon not previously involved in the treatment. The problem of lacking power in the comparison of the randomization groups is a limitation, as previously discussed. Moreover, the fact that our interpretation of the quality of life data is based on our patients’ ability to correctly recall their health status prior to the shoulder fracture may be considered a weakness. However, since a prospective collection of preinjury HRQoL data are not possible in trauma studies, we have to rely on preinjury recall or a comparison with population figures. Our patients’ assessment of their prefracture EQ-5Dindex score was slightly higher than in comparable age groups of the Swedish reference population,4 which may be explained by our inclusion criteria that selected healthier elderly individuals. Furthermore, a recent study reports that older patients can accurately recall their previous health status up to 6 weeks.26 Therefore, we believe that the effect of recall bias can be considered to be limited.
Conclusion In summary, the results of the study indicate an advantage in functional outcome and quality of life in favor of the locking plate, as compared to nonoperative treatment in elderly patients with a displaced 3-part fracture of the proximal humerus. The main advantage appeared to be an improved ROM. However, despite a modern fixation technique and overall good primary reductions in the locking plate group, 13% of the patients had a severe
P. Olerud et al. complication requiring a major reoperation and 17% had a minor secondary surgical intervention. The possible gain in function and HRQoL after treatment with a locking plate, balanced against the risk and inconvenience of surgery, is probably justified in the healthy elderly patient with high functional demands and when surgery is performed by an experienced surgeon. On the other hand, the overall acceptable outcome and limited need for secondary surgical interventions in the nonoperative group indicate that conservative treatment is probably sufficient for the most elderly patients with lower functional demands or when a surgeon with adequate experience is not available.
Disclaimer The authors, their immediate families, and any research foundations with which they are affiliated have not received any financial payments or other benefits from any commercial entity related to the subject of this article.
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