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Reverse shoulder arthroplasty for complex fractures of the proximal humerus in elderly patients: impact on the level of independency, early function, and pain medication
ARTICLE IN PRESS J Shoulder Elbow Surg (2017) ■■, ■■–■■
www.elsevier.com/locate/ymse
ORIGINAL ARTICLE
Reverse shoulder arthroplasty for complex fractures of the proximal humerus in elderly patients: impact on the level of independency, early function, and pain medication Fabian Wolfensperger, MDa,*, Patrick Grüninger, MDb, Michael Dietrich, MDb, Mathias Völlink, MDc, Emanuel Benninger, MDd, Michel Schläppi, MScd, Christoph Meier, MDd a
Department of Surgery, Zuger Kantonsspital, Baar, Switzerland Department of Surgery, Stadtspital Waid, Zürich, Switzerland c Department of Orthopedics, Kantonsspital Frauenfeld, Frauenfeld, Switzerland d Department of Orthopedics and Traumatology, Kantonsspital Winterthur, Winterthur, Switzerland b
Background: This study investigated early functional outcome, quality of life, and the level of independency in elderly patients after primary reverse shoulder arthroplasty (RSA) for complex fractures of the proximal humerus. Methods: This was a prospective case series that included 33 patients, aged ≥70 years, with a high level of independency who received RSA for complex fractures of the humerus (Orthopaedic Trauma Association B2/C) from January 2012 to April 2014. Results: Level of independency, quality of life (Short Form 36 Health Survey score), early functional outcome (Constant-Murley score, Disabilities of the Arm, Shoulder and Hand Outcome Measure), and pain medication (World Health Organization grading) were obtained at the 6-month follow-up and 1 year after surgery. The Constant-Murley score was 64 ± 14 after 6 months and 71 ± 12 at 1 year (P < .001), reaching 87% compared with the contralateral shoulder. The Disabilities of the Arm, Shoulder and Hand score reached 29 ± 20 at 6 months and 30 ± 21 at 1 year. The Short Form 36 score was comparable to normative data. After 6 months, 84% of our study group were back at their previous level of independency. Within 1 year, this rate increased to 91%. At the 1-year follow-up, analgesia intake was back at the level before the injury in 97% of the patients. Conclusions: Primary RSA provides good early functional results, reliable pain control, and excellent restoration of an independent life style in elderly patients. Thus, RSA may be considered for active patients with a high demand on shoulder function.
The Kantonale Ethik-Kommission Zürich approved this study (KEK-ZH-Nr. 2016-01184). *Reprint requests: Fabian Wolfensperger, MD, Department of Surgery, Zuger Kantonsspital, Landhausstrasse 11, CH-6340 Baar, Switzerland. E-mail address: [email protected] (F. Wolfensperger). 1058-2746/$ - see front matter © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. http://dx.doi.org/10.1016/j.jse.2017.01.021
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F. Wolfensperger et al. Level of evidence: Level IV; Case Series; Treatment Study © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. Keywords: Reverse shoulder arthroplasty; RSA; proximal humeral fracture; outcome; level of independence; CMS; DASH
Fractures of the humeral head are among the most common fractures in elderly patients. The treatment of these fractures is known to be prone to various complications, such as humeral head necrosis and loss of function of the rotator cuff.7,16,33,34 Thus, functional outcome is frequently poor. A relevant decrease of shoulder function may be associated with a decreased quality of life and a potential loss of an independent life, in particular for elderly patients. For these patients, the preservation of an independent life is the most important goal among others such as function, pain control, and a low complication rate. Preservation of an independent life may also be the most important factor to lower overall costs. Thus, not only purely functional outcome but also the degree of an independent life should be taken into consideration for the assessment of different therapeutic modalities for complex fractures of the proximal humerus. The purpose of this study was to prospectively assess reverse shoulder arthroplasty (RSA) as the primary treatment option in elderly patients with complex fractures of the humeral head, focusing on early functional outcome and its influence on potential social implications such as a partial or total loss of independence. Our hypothesis was that RSA may provide good functional results associated with preservation of the patient’s social situation as it presented before trauma.
Materials and methods Patients This prospective single-center study included all patients aged ≥70 years who were treated with primary RSA for acute complex fractures of the proximal humerus between January 2012 and April 2014. Fracture patterns treated with RSA included 3- and 4-part fractures according to Neer27 or 11-B and 11-C fractures according to the Orthopaedic Trauma Association (OTA)/Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification, respectively.23,25 These fracture patterns are generally associated with a high risk of subsequent avascular necrosis of the humeral head.13 Patients aged <70 years and patients with RSA for sequelae of failed nonoperative treatment, osteosynthesis, or fracture hemiarthroplasty (HA) were excluded (n = 10) from further evaluation. Informed consent was obtained from all patients entering the study and for the operative treatment and the follow-up investigations.
Preoperative assessment The preoperative evaluation included a clinical examination and the patient’s history, with a focus on the pretraumatic shoulder function and the preoperative way of life. The level of independency was
defined as follows: independently living at home, depending on some help at home, living in a retirement home, living in a nursing home with additional support.8 Only patients with higher levels of independency (living at home or in a retirement home) were included, patients living in a nursing home were excluded. The use of analgesia before trauma was recorded and classified according to the official World Health Organization (WHO) analgesic ladder.37 All patients received a standard series of x-rays (true anteroposterior shoulder view in neutral rotation [Grashey view], scapular Y view). All fractures were additionally assessed by a computed tomography (CT) scan (128-slice technology with 3-dimensional reconstructions) for a better understanding of the injury regarding fracture classification and potential compromise of humeral head perfusion.13
Operative technique and rehabilitation All patients received the same RSA model (Aequalis-Reversed Fracture; Tornier S.A.S., Montbonnot Saint Martin, France). All operations were performed with the patient in the beach chair position by the second (P.G.) or last (C.M.) author. General anesthesia was combined with a continuous interscalene block in all patients. A standard deltopectoral approach was used. The base plate was attached to the glenoid surface in an inferior position with a 10° inferior tilt. The stem was placed in the proximal humerus using thirdgeneration cementing technique (TBCem G1, Tornier) in the determined height and a retrotorsion of 25°. Tuberosity fixation was performed with 4 doubled-over strands of heavy nonabsorbable braided polytetrafluoroethylene-impregnated polyester suture (NiceLoop, Tornier) according to the technique described by Boileau et al.2 Cancellous bone grafts harvested from the resected humeral head were used to fill any remaining osseous defects. All patients were immobilized postoperatively on an abduction pillow (30°) for 6 weeks. Patients were encouraged to perform active wrist and elbow movements from the beginning, but no mobilization of the shoulder was allowed for 6 weeks. This was followed by physiotherapy of the shoulder with free active range of motion. Strengthening exercises were started at week 13.
Follow-up Intraoperative and postoperative complications and reinterventions were recorded. Follow-up investigations were performed after 6 and 12 months. The clinical evaluation included the Constant-Murley score (CMS).5 The age-adjusted and gender-adjusted CMS17 and the CMS of the contralateral shoulder were assessed as well. The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure15 and Short Form 36 Health Survey (SF-36)36 questionnaires were completed by the patients at home after receiving proper instructions by the investigators and were returned by mail. The social situation and intake of analgesic medication were assessed using the
ARTICLE IN PRESS RSA for proximal humeral fractures definitions described above. In addition, the patients were asked to rate their level of satisfaction as excellent, good, fair, or poor. All patients underwent a standardized radiographic evaluation at follow-up, including a true anteroposterior radiograph in neutral rotation, a scapular Y view, and an axillary view. X-ray series were analyzed for signs of scapular notching and implant loosening as well as the quality and position of the tuberosities after 1 year. Scapular notching was defined according to Levigne et al.21 Bone loss was graded according to the Sirveaux classification.31 Resorption of a tuberosity was defined as partial (size <50% in relation to the initial postoperative radiographs) or complete. Displacement was defined as migration >5 mm compared with the postoperative radiographs.19 All follow-up investigations were performed by the second (P.G.) or last (C.M.) author. X-ray images were also analyzed by these 2 authors and a senior radiologist who was not involved in other aspects of the study.
Statistical evaluation A statistical analysis was performed using IBM SPSS Statistics for Windows 21.0 software (IBM Corp., Armonk, NY, USA). A paired t test was used to compare the different scores at the 6-month and 1-year postoperative follow-up assessments. Spearman rank correlation analysis was performed to study the relationship between functional outcome and the resorption of the tuberosities. The significance level was set at P < .05.
Results Patients Between January 2012 and April 2014, 33 consecutive patients could be included. Mean age was 80 ± 6 years. There were 5 men and 28 women (85% female). According to the Neer classification,27 there were 15 three-part, 17 four-part fractures, and 1 anterior dislocation with an associated 4-part fracture. Applying the OTA/AO classification,23,25 we recorded 8 B2, 24 C2, and 1 C3 fractures. All fractures were the result of a low-energy trauma. The dominant shoulder was affected in 12 patients (36%). The mean interval between injury and surgery was 7 ± 5 days (range, 2-20 days) in our Table I Score
3 study group. The indication for RSA in 30 patients was based on the initial fracture pattern. Surgery was performed in 3 patients after early secondary fracture displacement. Intraoperatively, a complete tear of the supraspinatus tendon was seen in 12 patients (36%), and the infraspinatus was torn in 3 (9%). One patient (3%) presented with a tear of the upper third of the subscapularis tendon. Mean hospital length of stay was 13 ± 5 days (range, 8-32 days).
Complications A single cerclage of the proximal humeral shaft had to be performed in 3 patients (9%) as a result of an iatrogenic fracture after reaming. All of these fractures healed uneventfully. No other intraoperative complications were recorded. We observed neither any implant-related postoperative infection nor any relevant hematoma. No revision operations were performed.
Follow-up Of the initial 33 patients who were enrolled in this series, 32 (97%) were available for the 1-year follow-up assessment. All of these patients had a complete follow-up investigation, including clinical evaluation and radiologic assessment. One patient (3%) was not available for the 1-year follow-up due to a serious medical condition. Two patients (6%) missed their clinical and radiologic evaluation after 6 months; however, their social situation and analgesia intake were retrospectively assessed.
Shoulder function and pain The overall functional score results are reported in Table I. The mean absolute and relative CMSs both demonstrated a significant improvement after 12 months compared with the first follow-up after 6 months. The DASH scores showed no significant change over time. Before the trauma, most patients had not been regularly using analgesic medication (Table II). The use of analgesics
Functional scores
*
6-month follow-up
1-year follow-up
P value
64 ± 14 (35-84) 12 ± 4 (1-15) 17 ± 4 (9-20) 25 ± 6 (12-38) 10 ± 4 (5-18) 95 ± 20 (54-125) 79 ± 16 (42-108) 29 ± 20 (1-66)
71 ± 12 (46-94) 13 ± 3 (4-15) 18 ± 3 (10-20) 28 ± 5 (18-40) 13 ± 5 (4-25) 106 ± 16 (72-139) 87 ± 9 (58-102) 30 ± 21 (1-68)
<.001 .152 .005 <.001 <.001 <.001 <.001 .246
5
CMS Total (maximum 100 points) Pain (15 points) Activity level (20 points) Range of motion (40 points) Strength (25 points) CMS relative to age- and gender-adapted score,17 % CMS relative to opposite side, % DASH score15 (0 = no disability, 100 = maximum disability)
CMS, Constant-Murley Score; DASH, Disabilities of the Arm, Shoulder and Hand Outcome Measure. * Data are given as mean ± standard deviation (range).
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F. Wolfensperger et al. Table II Pain medication according to the World Health Organization grading37 WHO grade
None Level I Level II Level III
Before trauma
6-month follow-up
1-year follow-up
(n = 32)
(n = 32)
(n = 32)
No. (%)
No. (%)
No. (%)
27 (84) 3 (9) 0 (0) 2 (6)
24 (75) 5 (16) 1 (3) 2 (6)
26 (81) 4 (13) 0 (0) 2 (6)
WHO, World Health Organization.
Table III
Radiologic outcome at 1-year follow-up
Outcome
No. (%) (N = 32)
Greater tuberosity Secondary displacement Partial resorption Total resorption Lesser tuberosity Secondary displacement Partial resorption Total resorption Loosening No Yes Scapular notching31 None Grade I Grade II Grade III Grade III
2 (6) 13 (41) 6 (19) 2 (6) 5 (16) 6 (19) 32 (100) 0 (0) 20 (63) 7 (22) 5 (16) 0 (0) 0 (0)
decreased after surgery, approaching the level of the situation before trauma at the 6-month follow-up. We observed unchanged analgesic intake in 91% (29 of 32 patients) of our study group after 6 months and in 97% after 12 months.
Radiologic evaluation The radiological results are reported in detail in Table III. Secondary displacement of the greater tuberosity was noted in 2 patients (6%). The lesser tuberosity was displaced in 2 patients (6%) as well. Partial or total resorption of the greater tuberosity was seen in 19 patients (59%). The lesser tuberosity was affected in 11 (34%). However, no correlation was found regarding functional outcome and resorption of the tuberosities. After 1 year, there was no sign of loosening of the humeral or glenoid component. Scapular notching was present in 12 patients (38%).31
Level of independency and quality of life The social situation regarding independency before trauma and at follow-up after 6 and 12 months is reported in Table IV. At the 6-month follow-up, 84% of our cohort had reached their previous lifestyle. Five patients (16%) depended on an increased level of support compared with their situation before the trauma. After 12 months, 91% of our study group were back at their previous level of independency, but 3 patients (9%) required increased support. No patient had to give up life at home. The SF-36 score, including its subscores, showed no significant change over time (Table IV). Subjective outcome at 12 months was rated excellent by 22 patients (69%) and good by 10 patients (31%).
Discussion Primary RSA for complex fractures of the proximal humerus in our elderly study group was associated with a low complication rate and only minor impairment regarding shoulder function compared with the uninjured contralateral side at 1 year of follow-up (87%). The level of independency and quality of life could be maintained in most of our patients.
Complications By using the Nationwide Inpatient Sample database for 2011, Schairer et al28 analyzed 7714 patients who received RSA (27.4%) or HA (72.6%) for treatment of a proximal humeral fracture. Overall, in-hospital complication rates were similar in both groups: systemic complications occurred in 1.85% and 2.21%, respectively, and local complications in 2.73% and 1.66%, respectively. These complication rates are much lower than reported in other studies. However, only inhospital complications were provided. No revision surgery was performed in our cohort; however in 3 patients (9%), a crack of the proximal humerus metaphysis, which occurred during progressive reaming, had to be secured with a cerclage before the stem was finally placed.
Functional outcome Our clinical results are similar to other series published in the current literature. Dezfuli et al6 reported a CMS of 70 in elderly patients with a follow-up of 34 months after primary RSA. Klein et al18 achieved a similar CMS of 68, although the tuberosities were excised in all patients. Age may influence the outcome significantly. Lopiz et al22 showed that the CMS was significantly lower in patients aged ≥80 years compared with a younger group aged 75 to 79 years. Although most authors found favorable clinical outcomes of RSA compared with HA in the most recent literature, this observation is not uniform. In a blind, randomized controlled prospective study from 2014, RSA was compared with HA for proximal humeral fractures in patients aged ≥70 years
ARTICLE IN PRESS RSA for proximal humeral fractures Table IV
Level of independency and quality of life
Assessment
*
Level of independency Independently living at home Depending on some help at home Living in a retirement home Living in a nursing home (additional support) SF-36 quality of life scores Mental component summary36† Physical component summary36‡
5
Before trauma
6-month follow-up
1-year follow-up
(n = 32)
(n = 32)
(n = 32)
22 (69) 8 (25) 2 (6) 0 (0)
18 (56) 11 (34) 3 (9) 0 (0)
19 (59) 11 (34) 2 (6) 0 (0)
51 ± 11 (26-65) 44 ± 9 (23-58)
49 ± 12 (23-71) 43 ± 11 (22-58)
P value
.399 .377
SF-36, Short Form 36 Health Survey. * Data are given as number (%) or as mean ± standard deviation (range). † Scored as 62 = optimal quality of life; 17 = worst possible quality of life. ‡ Scored as 58 = optimal quality of life; 20 = worst possible quality of life.
with a minimum follow-up of 2 years.29 The CMS (56 vs. 40) and all its subscores were significantly better for RSA, and only internal rotation was similar to HA. Other researches did not report any advantages of RSA.26,32 In the most comprehensive review article so far, Brorson et al3 analyzed 18 studies containing 430 RSAs in acute fractures. The median CMS was 53 (range, 44-68) for RSA. They concluded that the functional outcome of RSA is not clearly superior compared with HA. The main disadvantage of HA is its dependence on tuberosity healing for a good clinical outcome.2 In contrast, acceptable to good clinical results can be achieved with RSA even when the tuberosities are resected. Gallinet et al11 reported a series of 16 patients with RSA. In only 1 patient the tuberosities were reinserted, in all the others, the tuberosities and cuff were removed. After a mean follow-up of 1 year, the CMS was 53 and the DASH was 37. We found no correlation between functional outcome and tuberosity healing. Of interest, the intraoperative assessment of the rotator cuff revealed a complete tear of the supraspinatus tendon in more than one-third of our patients. Some of the lesions may be attributed to a degenerative origin, others might exclusively— or at least partly—be caused by the recent shoulder trauma. However, one could hypothesize that this subgroup benefited the most from RSA because it is well known that these patients are expected to have poor shoulder function after osteosynthesis or HA even in the presence of osseous consolidation.1,12
Pain Pain control is one of the most important outcome measurements after trauma. RSA usually provides excellent pain control.4,11,24 However, the results for conventional HA are similar without any clear advantage for one above the other.26 The current study assessed pain as part of the CMS and by an analysis of the patients’ analgesia medication, which was rated according to the official WHO grading.37 Pain control
was excellent after 1 year, with all but 1 patient remaining in the same WHO level they had been before the injury.
Radiologic outcome A recent meta-analysis35 revealed a better rate of healed tuberosity in the RSA patients compared with HA (84% vs. 47%). Tuberosity healing may be better for RSA because less force is transmitted to the greater tuberosity as a result of altered biomechanics. This may provide a more favorable environment for healing compared with HA.30 In our study group, a total resorption of the greater and the lesser tuberosity was observed in 19%. The clinical significance of scapular notching remains unclear. It seems to increase with time. Cazeneuve and Cristofari4 reported a rate of 57% after a mean follow-up of 86 months. A systematic review3 reported scapular notching was evident with a median of 25%. In our series, scapular notching was seen in 38%, all being grade I or II. However, compared with other studies, our follow-up was only 1 year and an increased rate has to be expected over time.
Level of independency and quality of life Many studies have mainly investigated functional outcome of RSA, but only a few have addressed its social implications for the affected individual such as loss of independency and institutionalization.7,9,24 In particular for elderly patients, the importance of functional outcome may be of inferior importance compared with the effect on the level of independency. Furthermore, a decrease of independency may be associated with increased long-term costs to finance professional care. In a retrospective German study,9 the ability of daily living management was analyzed in 52 patients with isolated proximal fractures of the humerus unrelated to different treatment patterns. At 4 months after trauma, 17% had to give up their own housekeeping, living subsequently in a retirement home. These patients were not monitored longer;
ARTICLE IN PRESS 6 however, the authors assumed the number would further rise with time and emphasized the socioeconomic effect of these injuries. Merschin and Stangl24 reported a very good preservation of independency similar to our observations. Only 3% of their study group had to be permanently institutionalized after RSA. However, 85% of geriatric patients who underwent HA for complex proximal fractures of the humerus were still able to live by themselves in their original environment despite a distinctly lower CMS compared with the uninjured side (41 vs. 77).8 The outcome of the SF-36 score and its mental and physical subscores in our study were similar to the normative data of the German population aged >75 years.10 Obviously, the subjective impairment of the shoulder as expressed in a DASH score of 30 had no negative effect on the quality of life (SF36). Despite an improved objective shoulder function, we did not see a corresponding increase of the SF-36 values between the follow-up at 6 months and after 12 months. This observation is supported by the findings of other study groups that found no clear correlation between shoulder function and quality of life in elderly patients after different treatment modalities for proximal fractures of the humerus.22,33 Comparing the outcome of HA and osteosynthesis for Neer VI fractures, Spross et al33 found no difference between subgroups regarding the SF-36 score despite significant differences of shoulder function.33 They concluded that shoulder function impairment after a complex fracture of the proximal humerus had little effect on the quality of life in elderly patients. The decision to perform RSA or conventional HA may be made on an individual basis focusing on the particular needs of the patient regarding shoulder function. RSA may be considered for active elderly individuals with a high demand on shoulder function, whereas HA may still be a good choice for a less active, institutionalized elderly patient with lower demands.
Limitations The number of our patients is rather low, but there are no data available in the literature regarding the minimal clinically important difference for the overall CMS for patients undergoing RSA for complex fractures of the proximal humerus. For rotator cuff repair, values of 10.4 and 15 points have been determined to be significant.14,20 Based on an even smaller difference in our study group with an estimated drop-out of 10% after 1 year with a 2-sided significance of 0.05 and a power of 0.8, 30 patients would be required. Furthermore, follow-up is rather short compared with other investigations.11,18,22,24,29 However, because we focused on the effect of RSA on early restoration of function and its effect on the preservation of an independent life style, long-term results were beyond the scope of this study. There is no true control group with which outcome measures could be compared, and the shoulder function before the trauma is not known.
F. Wolfensperger et al. We only included patients with a high level of independency because we thought that independent and active patients would benefit most from good restoration of shoulder function. In contrast, the main focus in patients with lower demand may be rather pain control than function. By applying the above-mentioned inclusion criteria, we have certainly produced a selection bias. This bias must be considered when our results are compared with the results of other studies with different inclusion criteria. Although the level of independency and the need for longterm support, ranging from professional home care to nursing homes, were among the main outcome parameters in this study, their effect on the socioeconomic consequences and overall costs was not investigated.
Conclusions Primary RSA provides good early functional results, reliable pain control, and excellent restoration of an independent life style in elderly patients. Thus, it may be considered for active patients with a high demand on shoulder function.
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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36.
37.
fractures in the geriatric patient: results, health-related quality of life and complication rates. Int Orthop 2016;40:771-81. http://dx.doi.org/ 10.1007/s00264-015-3085-z Marsh JL, Slongo TF, Agel J, Broderick JS, Creevey W, DeCoster TA, et al. Fracture and dislocation classification compendium—2007: Orthopaedic Trauma Association classification, database and outcomes committee. J Orthop Trauma 2007;21:S1-6. Merschin D, Stangl R. Proximal humeral fractures in the elderly: quality of life, clinical results and institutionalization following primary reverse fracture arthroplasty. Unfallchirurg 2015;119:1015-22. http://dx.doi .org/10.1007/s00113-015-0009-8 [In German] Müller ME, Heim U, Nazarian S, Koch P, Schatzker J. The comprehensive classification of fractures of long bones. Berlin, Heidelberg: Springer; 2012. ISBN 9783642612619. Namdari S, Horneff JG, Baldwin K. Comparison of hemiarthroplasty and reverse arthroplasty for treatment of proximal humeral fractures: a systematic review. J Bone Joint Surg Am 2013;95:1701-8. http://dx.doi.org/10.2106/JBJS.L.01115 Neer CS 2nd. Displaced proximal humeral fractures. Part I. Classification and evaluation. By Charles S. Neer, I, 1970. Clin Orthop Relat Res 1987;223:3-10. Schairer WW, Nwachukwu BU, Lyman S, Craig EV, Gulotta LV. Reverse shoulder arthroplasty versus hemiarthroplasty for treatment of proximal humerus fractures. J Shoulder Elbow Surg 2015;24:1560-6. http://dx.doi.org/10.1016/j.jse.2015.03.018 Sebastiá-Forcada E, Cebrián-Gómez R, Lizaur-Utrilla A, Gil-Guillén V. Reverse shoulder arthroplasty versus hemiarthroplasty for acute proximal humeral fractures. A blinded, randomized, controlled, prospective study. J Shoulder Elbow Surg 2014;23:1419-26. http://dx .doi.org/10.1016/j.jse.2014.06.035 Shukla DR, McAnany S, Kim J, Overley S, Parsons BO. Hemiarthroplasty versus reverse shoulder arthroplasty for treatment of proximal humeral fractures: a meta-analysis. J Shoulder Elbow Surg 2016;25:330-40. http://dx.doi.org/10.1016/j.jse.2015.08.030 Sirveaux F, Favard L, Oudet D, Huquet D, Walch G, Mole D. Grammont inverted total shoulder arthroplasty in the treatment of glenohumeral osteoarthritis with massive rupture of the cuff. Results of a multicentre study of 80 shoulders. J Bone Joint Surg Br 2004;86:388-95. http://dx.doi.org/10.1302/0301-620X.86B3.14024 Sirveaux F, Navez G, Favard L, Boileau P, Walch G, Molé D. Reverse prosthesis for acute proximal humerus fracture, the multicentric study. In: Reverse shoulder arthroplasty: clinical results - complications revision. Montpellier, France: Sauramps Medical; 2006. p. 73-80. ISBN-13: 978-2840234678 Spross C, Platz A, Erschbamer M, Lattmann T, Dietrich M. Surgical treatment of Neer group VI proximal humeral fractures: retrospective comparison of PHILOS(R) and hemiarthroplasty. Clin Orthop Relat Res 2012;470:2035-42. http://dx.doi.org/10.1007/s11999-011-2207-1 Spross C, Platz A, Rufibach K, Lattmann T, Forberger J, Dietrich M. The PHILOS plate for proximal humeral fractures–risk factors for complications at one year. J Trauma Acute Care Surg 2012;72:783-92. http://dx.doi.org/10.1097/TA.0b013e31822c1b5b Wang J, Zhu Y, Zhang F, Chen W, Tian Y, Zhang Y. Meta-analysis suggests that reverse shoulder arthroplasty in proximal humerus fractures is a better option than hemiarthroplasty in the elderly. Int Orthop 2016;40:531-9. http://dx.doi.org/10.1007/s00264-015-2811-x Ware JE Jr, Gandek B. Overview of the SF-36 Health Survey and the International Quality of Life Assessment (IQOLA) project. J Clin Epidemiol 1998;51:903-12. World Health Organization. Cancer pain relief. With a guide to opioid availability. Geneva: World Health Organization; 1996.
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ORIGINAL ARTICLE
Reverse shoulder arthroplasty for complex fractures of the proximal humerus in elderly patients: impact on the level of independency, early function, and pain medication Fabian Wolfensperger, MDa,*, Patrick Grüninger, MDb, Michael Dietrich, MDb, Mathias Völlink, MDc, Emanuel Benninger, MDd, Michel Schläppi, MScd, Christoph Meier, MDd a
Department of Surgery, Zuger Kantonsspital, Baar, Switzerland Department of Surgery, Stadtspital Waid, Zürich, Switzerland c Department of Orthopedics, Kantonsspital Frauenfeld, Frauenfeld, Switzerland d Department of Orthopedics and Traumatology, Kantonsspital Winterthur, Winterthur, Switzerland b
Background: This study investigated early functional outcome, quality of life, and the level of independency in elderly patients after primary reverse shoulder arthroplasty (RSA) for complex fractures of the proximal humerus. Methods: This was a prospective case series that included 33 patients, aged ≥70 years, with a high level of independency who received RSA for complex fractures of the humerus (Orthopaedic Trauma Association B2/C) from January 2012 to April 2014. Results: Level of independency, quality of life (Short Form 36 Health Survey score), early functional outcome (Constant-Murley score, Disabilities of the Arm, Shoulder and Hand Outcome Measure), and pain medication (World Health Organization grading) were obtained at the 6-month follow-up and 1 year after surgery. The Constant-Murley score was 64 ± 14 after 6 months and 71 ± 12 at 1 year (P < .001), reaching 87% compared with the contralateral shoulder. The Disabilities of the Arm, Shoulder and Hand score reached 29 ± 20 at 6 months and 30 ± 21 at 1 year. The Short Form 36 score was comparable to normative data. After 6 months, 84% of our study group were back at their previous level of independency. Within 1 year, this rate increased to 91%. At the 1-year follow-up, analgesia intake was back at the level before the injury in 97% of the patients. Conclusions: Primary RSA provides good early functional results, reliable pain control, and excellent restoration of an independent life style in elderly patients. Thus, RSA may be considered for active patients with a high demand on shoulder function.
The Kantonale Ethik-Kommission Zürich approved this study (KEK-ZH-Nr. 2016-01184). *Reprint requests: Fabian Wolfensperger, MD, Department of Surgery, Zuger Kantonsspital, Landhausstrasse 11, CH-6340 Baar, Switzerland. E-mail address: [email protected] (F. Wolfensperger). 1058-2746/$ - see front matter © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. http://dx.doi.org/10.1016/j.jse.2017.01.021
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F. Wolfensperger et al. Level of evidence: Level IV; Case Series; Treatment Study © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. All rights reserved. Keywords: Reverse shoulder arthroplasty; RSA; proximal humeral fracture; outcome; level of independence; CMS; DASH
Fractures of the humeral head are among the most common fractures in elderly patients. The treatment of these fractures is known to be prone to various complications, such as humeral head necrosis and loss of function of the rotator cuff.7,16,33,34 Thus, functional outcome is frequently poor. A relevant decrease of shoulder function may be associated with a decreased quality of life and a potential loss of an independent life, in particular for elderly patients. For these patients, the preservation of an independent life is the most important goal among others such as function, pain control, and a low complication rate. Preservation of an independent life may also be the most important factor to lower overall costs. Thus, not only purely functional outcome but also the degree of an independent life should be taken into consideration for the assessment of different therapeutic modalities for complex fractures of the proximal humerus. The purpose of this study was to prospectively assess reverse shoulder arthroplasty (RSA) as the primary treatment option in elderly patients with complex fractures of the humeral head, focusing on early functional outcome and its influence on potential social implications such as a partial or total loss of independence. Our hypothesis was that RSA may provide good functional results associated with preservation of the patient’s social situation as it presented before trauma.
Materials and methods Patients This prospective single-center study included all patients aged ≥70 years who were treated with primary RSA for acute complex fractures of the proximal humerus between January 2012 and April 2014. Fracture patterns treated with RSA included 3- and 4-part fractures according to Neer27 or 11-B and 11-C fractures according to the Orthopaedic Trauma Association (OTA)/Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification, respectively.23,25 These fracture patterns are generally associated with a high risk of subsequent avascular necrosis of the humeral head.13 Patients aged <70 years and patients with RSA for sequelae of failed nonoperative treatment, osteosynthesis, or fracture hemiarthroplasty (HA) were excluded (n = 10) from further evaluation. Informed consent was obtained from all patients entering the study and for the operative treatment and the follow-up investigations.
Preoperative assessment The preoperative evaluation included a clinical examination and the patient’s history, with a focus on the pretraumatic shoulder function and the preoperative way of life. The level of independency was
defined as follows: independently living at home, depending on some help at home, living in a retirement home, living in a nursing home with additional support.8 Only patients with higher levels of independency (living at home or in a retirement home) were included, patients living in a nursing home were excluded. The use of analgesia before trauma was recorded and classified according to the official World Health Organization (WHO) analgesic ladder.37 All patients received a standard series of x-rays (true anteroposterior shoulder view in neutral rotation [Grashey view], scapular Y view). All fractures were additionally assessed by a computed tomography (CT) scan (128-slice technology with 3-dimensional reconstructions) for a better understanding of the injury regarding fracture classification and potential compromise of humeral head perfusion.13
Operative technique and rehabilitation All patients received the same RSA model (Aequalis-Reversed Fracture; Tornier S.A.S., Montbonnot Saint Martin, France). All operations were performed with the patient in the beach chair position by the second (P.G.) or last (C.M.) author. General anesthesia was combined with a continuous interscalene block in all patients. A standard deltopectoral approach was used. The base plate was attached to the glenoid surface in an inferior position with a 10° inferior tilt. The stem was placed in the proximal humerus using thirdgeneration cementing technique (TBCem G1, Tornier) in the determined height and a retrotorsion of 25°. Tuberosity fixation was performed with 4 doubled-over strands of heavy nonabsorbable braided polytetrafluoroethylene-impregnated polyester suture (NiceLoop, Tornier) according to the technique described by Boileau et al.2 Cancellous bone grafts harvested from the resected humeral head were used to fill any remaining osseous defects. All patients were immobilized postoperatively on an abduction pillow (30°) for 6 weeks. Patients were encouraged to perform active wrist and elbow movements from the beginning, but no mobilization of the shoulder was allowed for 6 weeks. This was followed by physiotherapy of the shoulder with free active range of motion. Strengthening exercises were started at week 13.
Follow-up Intraoperative and postoperative complications and reinterventions were recorded. Follow-up investigations were performed after 6 and 12 months. The clinical evaluation included the Constant-Murley score (CMS).5 The age-adjusted and gender-adjusted CMS17 and the CMS of the contralateral shoulder were assessed as well. The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure15 and Short Form 36 Health Survey (SF-36)36 questionnaires were completed by the patients at home after receiving proper instructions by the investigators and were returned by mail. The social situation and intake of analgesic medication were assessed using the
ARTICLE IN PRESS RSA for proximal humeral fractures definitions described above. In addition, the patients were asked to rate their level of satisfaction as excellent, good, fair, or poor. All patients underwent a standardized radiographic evaluation at follow-up, including a true anteroposterior radiograph in neutral rotation, a scapular Y view, and an axillary view. X-ray series were analyzed for signs of scapular notching and implant loosening as well as the quality and position of the tuberosities after 1 year. Scapular notching was defined according to Levigne et al.21 Bone loss was graded according to the Sirveaux classification.31 Resorption of a tuberosity was defined as partial (size <50% in relation to the initial postoperative radiographs) or complete. Displacement was defined as migration >5 mm compared with the postoperative radiographs.19 All follow-up investigations were performed by the second (P.G.) or last (C.M.) author. X-ray images were also analyzed by these 2 authors and a senior radiologist who was not involved in other aspects of the study.
Statistical evaluation A statistical analysis was performed using IBM SPSS Statistics for Windows 21.0 software (IBM Corp., Armonk, NY, USA). A paired t test was used to compare the different scores at the 6-month and 1-year postoperative follow-up assessments. Spearman rank correlation analysis was performed to study the relationship between functional outcome and the resorption of the tuberosities. The significance level was set at P < .05.
Results Patients Between January 2012 and April 2014, 33 consecutive patients could be included. Mean age was 80 ± 6 years. There were 5 men and 28 women (85% female). According to the Neer classification,27 there were 15 three-part, 17 four-part fractures, and 1 anterior dislocation with an associated 4-part fracture. Applying the OTA/AO classification,23,25 we recorded 8 B2, 24 C2, and 1 C3 fractures. All fractures were the result of a low-energy trauma. The dominant shoulder was affected in 12 patients (36%). The mean interval between injury and surgery was 7 ± 5 days (range, 2-20 days) in our Table I Score
3 study group. The indication for RSA in 30 patients was based on the initial fracture pattern. Surgery was performed in 3 patients after early secondary fracture displacement. Intraoperatively, a complete tear of the supraspinatus tendon was seen in 12 patients (36%), and the infraspinatus was torn in 3 (9%). One patient (3%) presented with a tear of the upper third of the subscapularis tendon. Mean hospital length of stay was 13 ± 5 days (range, 8-32 days).
Complications A single cerclage of the proximal humeral shaft had to be performed in 3 patients (9%) as a result of an iatrogenic fracture after reaming. All of these fractures healed uneventfully. No other intraoperative complications were recorded. We observed neither any implant-related postoperative infection nor any relevant hematoma. No revision operations were performed.
Follow-up Of the initial 33 patients who were enrolled in this series, 32 (97%) were available for the 1-year follow-up assessment. All of these patients had a complete follow-up investigation, including clinical evaluation and radiologic assessment. One patient (3%) was not available for the 1-year follow-up due to a serious medical condition. Two patients (6%) missed their clinical and radiologic evaluation after 6 months; however, their social situation and analgesia intake were retrospectively assessed.
Shoulder function and pain The overall functional score results are reported in Table I. The mean absolute and relative CMSs both demonstrated a significant improvement after 12 months compared with the first follow-up after 6 months. The DASH scores showed no significant change over time. Before the trauma, most patients had not been regularly using analgesic medication (Table II). The use of analgesics
Functional scores
*
6-month follow-up
1-year follow-up
P value
64 ± 14 (35-84) 12 ± 4 (1-15) 17 ± 4 (9-20) 25 ± 6 (12-38) 10 ± 4 (5-18) 95 ± 20 (54-125) 79 ± 16 (42-108) 29 ± 20 (1-66)
71 ± 12 (46-94) 13 ± 3 (4-15) 18 ± 3 (10-20) 28 ± 5 (18-40) 13 ± 5 (4-25) 106 ± 16 (72-139) 87 ± 9 (58-102) 30 ± 21 (1-68)
<.001 .152 .005 <.001 <.001 <.001 <.001 .246
5
CMS Total (maximum 100 points) Pain (15 points) Activity level (20 points) Range of motion (40 points) Strength (25 points) CMS relative to age- and gender-adapted score,17 % CMS relative to opposite side, % DASH score15 (0 = no disability, 100 = maximum disability)
CMS, Constant-Murley Score; DASH, Disabilities of the Arm, Shoulder and Hand Outcome Measure. * Data are given as mean ± standard deviation (range).
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F. Wolfensperger et al. Table II Pain medication according to the World Health Organization grading37 WHO grade
None Level I Level II Level III
Before trauma
6-month follow-up
1-year follow-up
(n = 32)
(n = 32)
(n = 32)
No. (%)
No. (%)
No. (%)
27 (84) 3 (9) 0 (0) 2 (6)
24 (75) 5 (16) 1 (3) 2 (6)
26 (81) 4 (13) 0 (0) 2 (6)
WHO, World Health Organization.
Table III
Radiologic outcome at 1-year follow-up
Outcome
No. (%) (N = 32)
Greater tuberosity Secondary displacement Partial resorption Total resorption Lesser tuberosity Secondary displacement Partial resorption Total resorption Loosening No Yes Scapular notching31 None Grade I Grade II Grade III Grade III
2 (6) 13 (41) 6 (19) 2 (6) 5 (16) 6 (19) 32 (100) 0 (0) 20 (63) 7 (22) 5 (16) 0 (0) 0 (0)
decreased after surgery, approaching the level of the situation before trauma at the 6-month follow-up. We observed unchanged analgesic intake in 91% (29 of 32 patients) of our study group after 6 months and in 97% after 12 months.
Radiologic evaluation The radiological results are reported in detail in Table III. Secondary displacement of the greater tuberosity was noted in 2 patients (6%). The lesser tuberosity was displaced in 2 patients (6%) as well. Partial or total resorption of the greater tuberosity was seen in 19 patients (59%). The lesser tuberosity was affected in 11 (34%). However, no correlation was found regarding functional outcome and resorption of the tuberosities. After 1 year, there was no sign of loosening of the humeral or glenoid component. Scapular notching was present in 12 patients (38%).31
Level of independency and quality of life The social situation regarding independency before trauma and at follow-up after 6 and 12 months is reported in Table IV. At the 6-month follow-up, 84% of our cohort had reached their previous lifestyle. Five patients (16%) depended on an increased level of support compared with their situation before the trauma. After 12 months, 91% of our study group were back at their previous level of independency, but 3 patients (9%) required increased support. No patient had to give up life at home. The SF-36 score, including its subscores, showed no significant change over time (Table IV). Subjective outcome at 12 months was rated excellent by 22 patients (69%) and good by 10 patients (31%).
Discussion Primary RSA for complex fractures of the proximal humerus in our elderly study group was associated with a low complication rate and only minor impairment regarding shoulder function compared with the uninjured contralateral side at 1 year of follow-up (87%). The level of independency and quality of life could be maintained in most of our patients.
Complications By using the Nationwide Inpatient Sample database for 2011, Schairer et al28 analyzed 7714 patients who received RSA (27.4%) or HA (72.6%) for treatment of a proximal humeral fracture. Overall, in-hospital complication rates were similar in both groups: systemic complications occurred in 1.85% and 2.21%, respectively, and local complications in 2.73% and 1.66%, respectively. These complication rates are much lower than reported in other studies. However, only inhospital complications were provided. No revision surgery was performed in our cohort; however in 3 patients (9%), a crack of the proximal humerus metaphysis, which occurred during progressive reaming, had to be secured with a cerclage before the stem was finally placed.
Functional outcome Our clinical results are similar to other series published in the current literature. Dezfuli et al6 reported a CMS of 70 in elderly patients with a follow-up of 34 months after primary RSA. Klein et al18 achieved a similar CMS of 68, although the tuberosities were excised in all patients. Age may influence the outcome significantly. Lopiz et al22 showed that the CMS was significantly lower in patients aged ≥80 years compared with a younger group aged 75 to 79 years. Although most authors found favorable clinical outcomes of RSA compared with HA in the most recent literature, this observation is not uniform. In a blind, randomized controlled prospective study from 2014, RSA was compared with HA for proximal humeral fractures in patients aged ≥70 years
ARTICLE IN PRESS RSA for proximal humeral fractures Table IV
Level of independency and quality of life
Assessment
*
Level of independency Independently living at home Depending on some help at home Living in a retirement home Living in a nursing home (additional support) SF-36 quality of life scores Mental component summary36† Physical component summary36‡
5
Before trauma
6-month follow-up
1-year follow-up
(n = 32)
(n = 32)
(n = 32)
22 (69) 8 (25) 2 (6) 0 (0)
18 (56) 11 (34) 3 (9) 0 (0)
19 (59) 11 (34) 2 (6) 0 (0)
51 ± 11 (26-65) 44 ± 9 (23-58)
49 ± 12 (23-71) 43 ± 11 (22-58)
P value
.399 .377
SF-36, Short Form 36 Health Survey. * Data are given as number (%) or as mean ± standard deviation (range). † Scored as 62 = optimal quality of life; 17 = worst possible quality of life. ‡ Scored as 58 = optimal quality of life; 20 = worst possible quality of life.
with a minimum follow-up of 2 years.29 The CMS (56 vs. 40) and all its subscores were significantly better for RSA, and only internal rotation was similar to HA. Other researches did not report any advantages of RSA.26,32 In the most comprehensive review article so far, Brorson et al3 analyzed 18 studies containing 430 RSAs in acute fractures. The median CMS was 53 (range, 44-68) for RSA. They concluded that the functional outcome of RSA is not clearly superior compared with HA. The main disadvantage of HA is its dependence on tuberosity healing for a good clinical outcome.2 In contrast, acceptable to good clinical results can be achieved with RSA even when the tuberosities are resected. Gallinet et al11 reported a series of 16 patients with RSA. In only 1 patient the tuberosities were reinserted, in all the others, the tuberosities and cuff were removed. After a mean follow-up of 1 year, the CMS was 53 and the DASH was 37. We found no correlation between functional outcome and tuberosity healing. Of interest, the intraoperative assessment of the rotator cuff revealed a complete tear of the supraspinatus tendon in more than one-third of our patients. Some of the lesions may be attributed to a degenerative origin, others might exclusively— or at least partly—be caused by the recent shoulder trauma. However, one could hypothesize that this subgroup benefited the most from RSA because it is well known that these patients are expected to have poor shoulder function after osteosynthesis or HA even in the presence of osseous consolidation.1,12
Pain Pain control is one of the most important outcome measurements after trauma. RSA usually provides excellent pain control.4,11,24 However, the results for conventional HA are similar without any clear advantage for one above the other.26 The current study assessed pain as part of the CMS and by an analysis of the patients’ analgesia medication, which was rated according to the official WHO grading.37 Pain control
was excellent after 1 year, with all but 1 patient remaining in the same WHO level they had been before the injury.
Radiologic outcome A recent meta-analysis35 revealed a better rate of healed tuberosity in the RSA patients compared with HA (84% vs. 47%). Tuberosity healing may be better for RSA because less force is transmitted to the greater tuberosity as a result of altered biomechanics. This may provide a more favorable environment for healing compared with HA.30 In our study group, a total resorption of the greater and the lesser tuberosity was observed in 19%. The clinical significance of scapular notching remains unclear. It seems to increase with time. Cazeneuve and Cristofari4 reported a rate of 57% after a mean follow-up of 86 months. A systematic review3 reported scapular notching was evident with a median of 25%. In our series, scapular notching was seen in 38%, all being grade I or II. However, compared with other studies, our follow-up was only 1 year and an increased rate has to be expected over time.
Level of independency and quality of life Many studies have mainly investigated functional outcome of RSA, but only a few have addressed its social implications for the affected individual such as loss of independency and institutionalization.7,9,24 In particular for elderly patients, the importance of functional outcome may be of inferior importance compared with the effect on the level of independency. Furthermore, a decrease of independency may be associated with increased long-term costs to finance professional care. In a retrospective German study,9 the ability of daily living management was analyzed in 52 patients with isolated proximal fractures of the humerus unrelated to different treatment patterns. At 4 months after trauma, 17% had to give up their own housekeeping, living subsequently in a retirement home. These patients were not monitored longer;
ARTICLE IN PRESS 6 however, the authors assumed the number would further rise with time and emphasized the socioeconomic effect of these injuries. Merschin and Stangl24 reported a very good preservation of independency similar to our observations. Only 3% of their study group had to be permanently institutionalized after RSA. However, 85% of geriatric patients who underwent HA for complex proximal fractures of the humerus were still able to live by themselves in their original environment despite a distinctly lower CMS compared with the uninjured side (41 vs. 77).8 The outcome of the SF-36 score and its mental and physical subscores in our study were similar to the normative data of the German population aged >75 years.10 Obviously, the subjective impairment of the shoulder as expressed in a DASH score of 30 had no negative effect on the quality of life (SF36). Despite an improved objective shoulder function, we did not see a corresponding increase of the SF-36 values between the follow-up at 6 months and after 12 months. This observation is supported by the findings of other study groups that found no clear correlation between shoulder function and quality of life in elderly patients after different treatment modalities for proximal fractures of the humerus.22,33 Comparing the outcome of HA and osteosynthesis for Neer VI fractures, Spross et al33 found no difference between subgroups regarding the SF-36 score despite significant differences of shoulder function.33 They concluded that shoulder function impairment after a complex fracture of the proximal humerus had little effect on the quality of life in elderly patients. The decision to perform RSA or conventional HA may be made on an individual basis focusing on the particular needs of the patient regarding shoulder function. RSA may be considered for active elderly individuals with a high demand on shoulder function, whereas HA may still be a good choice for a less active, institutionalized elderly patient with lower demands.
Limitations The number of our patients is rather low, but there are no data available in the literature regarding the minimal clinically important difference for the overall CMS for patients undergoing RSA for complex fractures of the proximal humerus. For rotator cuff repair, values of 10.4 and 15 points have been determined to be significant.14,20 Based on an even smaller difference in our study group with an estimated drop-out of 10% after 1 year with a 2-sided significance of 0.05 and a power of 0.8, 30 patients would be required. Furthermore, follow-up is rather short compared with other investigations.11,18,22,24,29 However, because we focused on the effect of RSA on early restoration of function and its effect on the preservation of an independent life style, long-term results were beyond the scope of this study. There is no true control group with which outcome measures could be compared, and the shoulder function before the trauma is not known.
F. Wolfensperger et al. We only included patients with a high level of independency because we thought that independent and active patients would benefit most from good restoration of shoulder function. In contrast, the main focus in patients with lower demand may be rather pain control than function. By applying the above-mentioned inclusion criteria, we have certainly produced a selection bias. This bias must be considered when our results are compared with the results of other studies with different inclusion criteria. Although the level of independency and the need for longterm support, ranging from professional home care to nursing homes, were among the main outcome parameters in this study, their effect on the socioeconomic consequences and overall costs was not investigated.
Conclusions Primary RSA provides good early functional results, reliable pain control, and excellent restoration of an independent life style in elderly patients. Thus, it may be considered for active patients with a high demand on shoulder function.
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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