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External Fixation Versus Volar Locking Plate for Unstable Dorsally Displaced Distal Radius Fractures—A 3-Year Follow-Up of a Randomized Controlled Study
EDITOR’S CHOICE
External Fixation Versus Volar Locking Plate for Unstable Dorsally Displaced Distal Radius Fractures—A 3-year Follow-Up of a Randomized Controlled Study Jenny Saving, MD,*† Anders Enocson, MD, PhD,*‡ Sari Ponzer, MD, PhD,*† Cecilia Mellstrand Navarro, MD, PhD*§ Purpose To determine if a volar locking plate (VLP) is superior to external fixation (EF) 3 years after surgery for unstable, dorsally displaced, distal radius fractures caused by lowenergy injury in patients 50 to 74 years of age. Methods During 2009 to 2013, 140 patients with an unstable dorsally displaced distal radius fracture were randomized to either VLP or EF. One hundred eighteen patients (EF 56, VLP 62) were available for a 3-year follow-up. The primary outcome was the Disabilities of the Arm, Shoulder, and Hand score (DASH) at 3 years. Secondary outcomes were Patient-Related Wrist Evaluation score (PRWE), EuroQol-5 Dimensions (EQ-5D) score, range of motion (ROM), grip strength, and radiological signs of osteoarthritis (OA) at 3 years. Moreover, reoperations and minor complications during the first 3 years were recorded. Results There were no differences regarding DASH, PRWE, EQ-5D, ROM or grip strength. The reoperation rate was 21% (13 of 62) in the VLP group compared with 14% (8 of 56) in the EF group. The OA rate was 42% (25 of 59) in the VLP group compared with 28% (15 of 53) in the EF group. Conclusions Three years after surgery for unstable dorsally displaced distal radius fractures, the clinical and radiological results for VLP and EF were comparable. (J Hand Surg Am. 2018;(-):-e-. Copyright Ó 2018 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic II. Key words Distal radius fracture, external fixation, randomized controlled study, surgical treatment, volar locking plate.
From the *Department of Clinical Science and Education, Södersjukhuset; the ‡Department of Molecular Medicine and Surgery, Karolinska University Hospital, Karolinska Institutet; the †Department of Orthopaedics; and the §Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden. Received for publication January 15, 2018; accepted in revised form September 26, 2018. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Corresponding author: Jenny Saving, MD, Department of Orthopaedics, Södersjukhuset Hospital, SE—118 83 Stockholm, Sweden; e-mail: [email protected]. 0363-5023/18/---0001$36.00/0 https://doi.org/10.1016/j.jhsa.2018.09.015
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displaced distal radius fractures remains controversial. Several studies report similar 1-year outcomes regardless of the treatment method.1e15 Shortterm results seem to favor surgical treatment with a volar plate over percutaneous methods.10,16e18 External fixation (EF) was introduced as a surgical treatment of distal radius fractures during the 1970s and has proven to give good results.19,20 An EF can be augmented with percutaneous pinning to add stability or to reduce intra-articular fractures.21,22 PTIMAL TREATMENT OF DORSALLY
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Commonly reported complications after EF and pinning are transient superficial nerve palsy, pin track infection, and loss of fracture reduction.19,20 However, severe complications are rare.23 Internal fixation with a volar locking plate (VLP) was introduced during the 1990s with good clinical and radiological results.24e28 It allows earlier movement of the wrist, which seems to be beneficial for earlier return of function. Common complications are median nerve palsy, flexor tenosynovitis, extensor tenosynovitis, and tendon rupture.29 In addition, 15% to 30% of all volar plates are removed within the first 1 to 2 years according to several studies.11,12,29,30 Few studies compare results beyond 1 year after distal radius fracture surgery. The total rate of complications seems to be similar after external fixation and VLPs, but VLPs have been associated with more complications requiring late secondary surgery.6,13,17,31,32 There are reports that secondary surgery occurs 2 to 7 years after fracture surgery,13,31e34 which makes long-term follow-up important, especially for patients treated with internal fixation left in place that may cause mechanical attrition of surrounding soft tissues. The purpose of this study was to perform a 3-year follow-up of patients aged 50 to 74 years, treated within the context of a randomized controlled trial comparing EF and VLP for dorsally displaced distal radius fractures caused by a low-energy injury. The primary aim was to investigate the null hypothesis that VLP is equal to EF 3 years after surgery in terms of the Disabilities of the Arm, Shoulder, and Hand (DASH) score.35 Secondary aims were to compare the outcome regarding the Patient-Rated Wrist Evaluation (PRWE) score,36 health-related quality of life, grip strength, range of motion (ROM), radiographic signs of osteoarthritis (OA), and complications.
proximal to the extensor pollicis longus muscle. The extensor carpi radialis longus and brevis tendons were retracted, and the radius was exposed for the application of 2 threaded 3-mm pins. Dorsolaterally, on the second metacarpal bone, 2 threaded 3-mm pins were introduced through stab incisions. The external fixator was attached, and the fracture was reduced under fluoroscopic control by means of ligamentotaxis. Additional 1.6-mm Kirschner wires were applied at the surgeon’s discretion. The external fixator and Kirschner wires were extracted at an outpatient office visit 5 to 6 weeks after surgery. The VLP fixation was performed via a straight incision over the flexor carpi radialis tendon, which was retracted ulnarly. The flexor tendon sheath was opened and the flexor pollicis longus tendon was held with retractors ulnarly. The pronator quadratus muscle was split and the fracture was exposed and reduced under fluoroscopic control. Fracture stabilization was achieved by applying a VLP proximal to the watershed line. Repair of the pronator quadratus was based on the judgment of the operating surgeon. The wrist was immobilized in a dorsal plaster orthosis for 4 weeks to diminish postoperative pain. All patients were encouraged to perform finger ROM exercises immediately after the surgical procedure. After removing the plaster orthosis or external fixator and any additional pins, all patients were referred to the occupational therapists in our department for standard rehabilitation. Results of the 1-year follow-up have been reported previously.13 In total, 134 (96%) patients, 65 in the EF group and 69 in the VLP group, completed the 1year follow-up. They were all contacted by mail and telephone and asked to participate in a 3-year followup, and 118 (84%) patients agreed to participate: 56 in the EF group and 62 in the VLP group (Fig. 1). Nine patients in the EF group declined to participate including 1 patient who had 3 reoperations: volar plate fixation owing to fracture redisplacement, carpal tunnel release, and plate extraction owing to flexor tenosynovitis. Seven patients in the VLP group declined to participate of whom 1 patient had been reoperated with plate extraction owing to flexor tenosynovitis. The study was registered at www.clinicaltrials.gov (NCT01034943, NCT01035359). The protocol was set up according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines37 and conformed to the ethical guidelines of the 1975 Declaration of Helsinki. Written informed consent was obtained from each patient. The study was approved by the Regional Ethical Review Board in Stockholm, Sweden, reference number 2012/1127-32.
METHODS In an earlier published study13 conducted at Södersjukhuset Hospital, Stockholm, Sweden, during September 2009 to February 2013, 140 patients with dorsally displaced distal radius fractures were prospectively randomized to surgery with either EF (Hoffman Compact T2; Stryker, Amsterdam, the Netherlands) with or without additional pinning (n ¼ 70), or VLP fixation (2.4-mm Variable Angle LCP Two-Column Volar Distal Radius Plate; Synthes, Zuchwil, Switzerland) (n ¼ 70). Inclusion and exclusion criteria are presented in Table 1. The external fixator was applied using a 4-cm dorsolateral incision J Hand Surg Am.
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was graded according to the scale of Knirk and Jupiter (0e3)45 and in the distal radioulnar joint (DRUJ) as present or not.
TABLE 1. Inclusion and Exclusion Criteria for Patients With Distal Radius Fracture for Selection to a Randomized Controlled Trial Comparing VLP and EF
Complications: Patients underwent a clinical examination for detection of complications. Moreover, patients were interviewed, and all patient records were investigated. All signs of complications prevailing at 3 years after surgery and all complications causing a reoperation were reported. Removal of external fixation was not considered a reoperation.
Inclusion Criteria Patient age (50e74 y for women and 60e74 y for men) Injury only after fall from standing height Wrist radiography of > 20 dorsal angulation and/or > 5 mm axial shortening (OTA class 23 A2, A3, C1, C2, C3) Good knowledge of written and spoken Swedish Fracture diagnosed within 72 h
Statistics: All results are presented according to the intention-to-treat principle. An a priori power calculation was performed to detect a 10-point difference in DASH 1 year after surgery at an 80% power level with a presumed SD of 20.46 The cohort needed was 64 patients in each group. The cohort available for the 3 years of follow-up was 53 and 59 patients, respectively, which makes our study underpowered for comparisons of primary and secondary outcomes. Level of significance was set to P less than .05 in 2-sided tests. Student t test was used for comparisons of means. Results are presented as the means with corresponding SDs and confidence intervals. Chi-square tests were performed for comparisons of proportions. Fisher exact test was used for comparison of proportions when expected numbers were less than 5 in any 1 cell of the contingency tables. Linear regression was performed to investigate any correlation between OA and clinical outcome.
Patient resident within the catchment area of the hospital Exclusion Criteria Former disability of either wrist Other concomitant injuries Rheumatoid arthritis or other severe joint disorder Dementia or Pfeiffer score* < 5 Drug or alcohol abuse or psychiatric disorder Dependency in activities of daily living Medical condition contraindicating general anesthesia OTA, Orthopaedic Trauma Association. *Adapted from Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatric Soc. 1975;23(10):433e441.
Outcome variables Patient-Reported Outcome Measures: The DASH score was the primary outcome.35 The PRWE score was investigated as a secondary outcome.36 Both scores are validated for the evaluation of distal radius fractures35,38 and translated and validated for use in Swedish.39,40 Both scores range from 0, which indicates no disability, to 100, which indicates maximum disability. The minimal clinically important difference for the DASH is considered to be 10 points41 and for the PRWE 11.5 points.42 Health-related quality of life was assessed by the EuroQol-5 Dimensions (EQ-5D) score.43 The score ranges from 0, which indicates the worst possible state, to 1, which indicates the best possible state of health-related quality of life.
RESULTS In total, 118 patients filled in the Patient-Reported Outcome Measures (PROM) questionnaires of whom 112 patients (53 in the EF group and 59 in the VLP group) also completed all clinical and radiological investigations. The 6 patients who filled in all questionnaires but did not participate in clinical and radiological evaluation gave their consent to medical record investigation. The mean follow-up time was 37 months (range, 34e48 months). Patient characteristics at baseline are presented in Table 2.
Grip strength and ROM: An independent occupational therapist investigated ROM and grip strength in the injured and uninjured extremity. Grip strength was measured using a Martin vigorimeter.44 The ROM and grip strength are presented as percentages of the uninjured side. Grip strength was not corrected for hand dominance, as suggested by Margaliot et al.23
PROMs There were no differences in PRWE, DASH, or EQ5D between the groups (Table 3). Between 1 year and 3 years, there were statistically significant improvements of equal size within each group for DASH (EF, 11.5 to 7.0; 95% confidence interval [95% CI, 2.3e6.8]; VLP, 10.5 to 5.4; 95%
Radiological evaluation: An independent radiologist investigated signs of OA. In the radiocarpal joint, it J Hand Surg Am.
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Eligible paƟents (n = 1349) Excluded Not meeƟng the inclusion criteria (n = 1055) No trial consultant or research nurse available (n = 86) Declined to parƟcipate (n = 51)
Randomized (n = 140)
Allocated to external fixaƟon (n = 70) Received allocated intervenƟon (n = 66) Did not receive allocated intervenƟon (surgeon´s choice) (n = 4)
Allocated to volar plate (n = 70) Received allocated intervenƟon (n = 70)
Exclusion due to not meeƟng inclusion criteria (n = 1) n = 69
Follow-up 2 weeks
n = 67
Follow-up 3 months
n = 70
Lost to follow-up Death (n = 1) Declined to parƟcipate (n = 1)
n = 70
Lost to follow-up Declined to parƟcipate (n = 1) No answer (n = 1)
Lost to follow up Declined to parƟcipate (n = 1)
n = 65
Follow-up 1 year
Lost to follow up Declined to parƟcipate (n = 9)
n = 69
Lost to follow up Declined to parƟcipate (n = 7)
n = 56 53 paƟents completed all variables For 3 paƟents only DASH, PRWE, and EQ-5D outcomes were recorded
Follow-up 3 years
n = 62 59 paƟents completed all variables For 3 paƟents only DASH, PRWE, and EQ-5D outcomes were recorded
FIGURE 1: Flow chart for inclusion of patients with distal radius fracture to a randomized controlled study comparing VLP and EF.
Radiological outcome There was no difference in radiological signs of OA in the radiocarpal or DRUJ; 42% (25 of 59) in the VLP group compared with 28% (15 of 53) in the EF group. Osteoarthritis was not correlated to clinical outcome as expressed by DASH. The study size was not large enough to make any statistical inferences regarding radiological outcome.
CI, 2.3e8.0) and PRWE (EF, 12.4 to 6.6; 95% CI, 3.0e8.5; VLP, 12.7 to 6.1; 95% CI, 3.3e9.9). However, these improvements did not reach the minimal clinically important difference. Grip strength and ROM There were no statistically significant differences in grip strength or ROM between groups (Table 4). Between 1 year and 3 years, there were improvements in grip strength in the EF group from 82% to 90% (95% CI, 3.4 to 12.6), and in the VLP group from 87% to 102%, (95% CI, e0.4 to 32.3). J Hand Surg Am.
Complications Twenty-one percent (13 of 62) of the patients in the VLP group compared with 14% (8 of 56) in the EF r
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patients were younger (mean, 42 years) than in our study and they included only intra-articular fractures. Furthermore, all dorsal plates were routinely removed after 6 months to avoid tendon attrition. As most studies report similar functional results regardless of surgical method at 1 year or later,1e10,12e15,31,32 it is important to consider the burden of complications. There were more reoperations (although not statistically significant) in the VLP group (13 patients) than in the EF group (8 patients) in our study, and most of the reoperations in the VLP group consisted of plate extraction owing to tendon or nerve symptoms: 11 of the plates were extracted in the VLP group and 5 of them were removed later than 1 year after initial surgery. Williksen et al32 reported a 31% (16 of 52) reoperation rate in the VLP group compared with 17% (10 of 59) in the EF group 5 years after initial surgery. In their study, 11 out of 52 plates were removed and 3 of them were taken out after the first year. Landgren et al31 reported a reoperation rate of 54% (14 of 26) in VLP patients compared with 41% (10 of 24) in EF patients 5 years after initial surgery. In the VLP group, 12 out of 26 plates were extracted. Esenwein et al30 examined 665 patients operated with VLP up to 2 years after surgery and had a reoperation rate of 10%. They reported 232 of 665 (35%) plate extractions but did not consider plate extraction as a complication. Because complications are relatively rare, larger study populations are needed to detect possible differences between groups. Our study was not powered to determine true differences between groups regarding complications. In a registry study from Sweden with 36,618 patients, there were significantly more reoperations for VLP patients than for EF patients.49 Furthermore, reoperations for EF patients occurred early and consisted mainly of secondary plate fixation owing to fracture displacement. Reoperations for VLP patients occurred late and consisted mainly of plate extractions. Registry studies are an efficient study design for detecting rare events in large patient populations, such as reoperations after wrist fracture surgery. An obvious problem, however, is that no control can be made for biases such as different case mixes with varying fracture severity. Large prospective controlled cohorts and/or multicenter trials with long-term follow-up are also needed to further elucidate complications after distal radius fracture surgery. There were significantly more scar adherences at 3 years in the EF group than in the VLP group. To our knowledge, there are no published long-term presentations of mild complications such as this, but
TABLE 2. Baseline Data at Inclusion for Patients Treated for Unstable Dorsally Displaced Distal Radius Fracture With External Fixation or VLP Available at 3-Y Follow-Up EF Group (n ¼ 56)
VLP Group (n ¼ 62)
Mean age, y (range)
63 (50e74)
63 (51e74)
Number of females
54 (96%)
55 (89%)
Number with injury to dominant hand
30 (54%)
23 (37%)
7 (13%)
10 (16%)
Smoker OTA classification A2
4 (7%)
3 (5%)
A3
15 (27%)
21 (34%)
C1
31 (55%)
33 (53%)
C2
4 (7%)
3 (5%)
C3
2 (4%)
2 (3%)
OTA, Orthopaedic Trauma Association.
group had had 1 or more reoperations. The study size was not large enough to make any statistical inferences regarding complications. All reoperations are presented in Table 5. In the VLP group, 11 of 62 patients had their plate removed. Five of these implant removals occurred during the second or third year after fracture, 4 owing to extensor tenosynovitis, and 1 owing to flexor tenosynovitis. Eight percent (5 of 59) of the patients in the VLP group compared with 60% (32 of 53) in the EF group had scar adherence. Minor nerve symptoms were present in 8% (4 of 53) of the EF patients compared with 3% (2 of 59) of the VLP patients. DISCUSSION The main finding of this study was that, 3 years after surgery for dorsally displaced distal radius fractures after low-energy trauma, neither DASH nor any of the other clinical or radiological outcomes differed between patients treated with EF or VLP. Our findings are supported by several other authors. Williksen et al32 reported no significant difference in DASH between EF and VLP after 5 years. Landgren et al31 found no difference in DASH between EF and fragment-specific plating after 5 years. Kreder et al8 found no difference in Musculoskeletal Functional Assessment score47 between EF and plating after 2 years. In contrast, Leung et al3 reported a better Gartland and Werley score48 2 years after surgery with volar and/or dorsal plates compared with EF, but the J Hand Surg Am.
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TABLE 3. PROM in Patients Treated for Unstable Dorsally Displaced Distal Radius Fracture With EF or VLP Available for 3-Year Follow-Up EF Group (n ¼ 56)
VLP Group (n ¼ 62)
Mean Difference
Mean DASH (SD)
7.0 (9.9)
5.4 (7.1)
1.6
Mean PRWE (SD)
6.6 (12.0)
6.1 (9.2)
0.5
e3.4 to 4.4
Mean EQ-5D (SD)
0.92 (0.13)
0.92 (0.13)
0.00
e0.04 to 0.05
95% CI e1.6 to 4.8
TABLE 4. Grip Strength and ROM in Patients Treated for Unstable Dorsally Displaced Distal Radius Fracture With EF or VLP Available for 3-Year Follow-Up EF Group (n ¼ 53)
VLP Group (n ¼ 59)
Mean Difference
Mean grip strength as % of uninjured wrist (SD)
90 (16)
102 (59)
12
e4.5 to 28.7
Mean dorsal extension as % of uninjured wrist (SD)
94 (12)
97 (14)
3
e2.5 to 7.5
Mean volar flexion as % of uninjured wrist (IQR)
89 (10)
93 (14)
4
e1.0 to 8.5
Mean radial deviation as % of uninjured wrist (IQR)
94 (11)
100 (13)
6
Mean ulnar deviation as % of uninjured wrist (IQR)
102 (15)
99 (13)
3
e2.6 to 7.9
Mean supination as % of uninjured wrist (IQR)
96 (8)
95 (11)
1
e3.0 to 4.0
Mean pronation as % of uninjured wrist (IQR)
100 (8)
99 (7)
1
e1.6 to 4.1
95% CI
0.9 to 10.0
IQR, interquartile range.
affect the long-term outcome. Based on these findings, other factors than final clinical outcome may influence treatment choices. In a setting with limited health care resources, cost-effective health care utilization is important. Tubeuf and colleagues52 evaluated the cost-effectiveness of operative treatment with plate fixation compared with operative treatment with percutaneous fixation (Kirschner wires) over a time perspective of 12 months. The analysis showed that plating was not cost-effective compared with treatment with K-wires in any age group. Another costeffectiveness study from Karantana et al53 reported that volar plating was not cost-effective compared with percutaneous treatments. A majority of patients in any fracture surgery practice may be opposed to the idea of an external fixation because of the appearance of the fixation device compared with internal fixation, regardless of equal clinical results in outcome studies. There may exist a difference in cultural acceptance in different areas of the world. Some patients may oppose carrying internal metalwork in their body and would,
there is supporting evidence of more complications that do not require surgery after EF compared with VLP.50,51 There were more patients with radiological signs of OA in the VLP group than in the EF group. This finding conflicts with the 2-year results of Leung et al,3 who showed that more OA was found among EF patients than among plated patients. An explanation for our findings could be that the plating procedure per se is putting the patient at risk for OA owing to the invasive nature of the surgical method. In our study, radiological evaluation took place of both the radiocarpal and the DRUJ, which may have caused a higher rate of OA compared with other studies. Jupiter and Marent-Huber28 evaluated a cohort of VLP patients and found a radiological radiocarpal OA rate of 27%, which is similar to our study. Unfortunately, our study is not large enough to ensure that our finding regarding OA is not a product of chance. Our study showed that the choice of surgical method for a distal radius fracture did not substantially J Hand Surg Am.
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TABLE 5. Reoperations in Patients With Unstable Dorsally Displaced Distal Radial Fractures Treated With EF or VLP at 3-Year Follow-Up Reoperation Secondary plating owing to fracture redisplacement
EF Group (n ¼ 56)
VLP Group (n ¼ 62)
3
2
Plate extraction Tenosynovitis
2*
8
Complex regional pain syndrome
0
1
Other Fasciotomy owing to compartment syndrome
0
2
0
1
Carpal tunnel release
1
1
Debridement owing to deep infection
1
0
Scar correction
2
0
Tendon transfer owing to extensor tendon rupture
0
1
Total
9†
16‡
*Converted during surgery to VLP or secondary plating owing to fracture redisplacement. †One patient had 2 reoperations—secondary plating owing to fracture redisplacement and subsequent plate extraction. ‡Three patients had 2 reoperations—1 had secondary plating owing to fracture redisplacement and subsequent plate extraction, 1 had fasciotomy owing to compartment syndrome and subsequent plate extraction, and 1 had carpal tunnel release and subsequent plate extraction.
if offered, choose fixation where no hardware is left after fracture healing. Obviously, plate removal would solve this matter but that would involve higher treatment costs and risks for surgical complications. No study has been performed investigating patients’ own experiences of radius fracture treatments, and there is a paucity of published data regarding any qualitative matter in fracture surgery. In a recently published qualitative study of patients treated for a distal radius fracture, Huetteman et al54 found that most patients prefer shared decision making regarding choice of treatment. It should be of interest for future clinicians and researchers to investigate patients’ personal opinions, experiences, and preferences and include those factors in the decision making regarding distal radius fracture care. One limitation of our study was that 12% of patients did not complete the 3-year follow-up. We do not know the reasons why these patients refused the follow-up, but we do not believe that the difference in loss to follow-up affects the overall findings of our study. Because of the dropouts, we did not reach the number of 64 patients in each arm that we calculated in our power estimation. Furthermore, neither patients nor investigators were blinded to the intervention and we did not perform any inter- or intraobserver validity testing for our radiological interpretation. Our study has several strengths. It is a large cohort of randomized patients in a homogeneous study population. All data were prospectively collected, and patient records were checked for accuracy according to J Hand Surg Am.
the study protocols. Our study has a 3-year follow-up and is, therefore, 1 of very few studies that report a comparison of clinical results, PROMs, and complication rate for EF and VLP beyond a 1-year follow-up. In conclusion the clinical and radiological outcome was comparable after VLP and EF 3 years after surgery for unstable, dorsally displaced distal radius fractures caused by low-energy trauma in patients aged 50 to 74 years. Volar plating might be associated with more reoperations than EF. More and larger studies of long-term results after distal radius fracture surgery are warranted. ACKNOWLEDGMENTS This study was conducted with funding by the Swedish Research Council and the Regional Agreement on Medical Training and Clinical Research between the Stockholm County Council and Karolinska Institutet (ALF). REFERENCES 1. Abramo A, Kopylov P, Geijer M, Tagil M. Open reduction and internal fixation compared to closed reduction and external fixation in distal radial fractures: a randomized study of 50 patients. Acta Orthop. 2009;80(4):478e485. 2. Xu GG, Chan SP, Puhaindran ME, Chew WY. Prospective randomised study of intra-articular fractures of the distal radius: comparison between external fixation and plate fixation. Ann Acad Med Singapore. 2009;38(7):600e606. 3. Leung F, Tu YK, Chew WY, Chow SP. Comparison of external and percutaneous pin fixation with plate fixation for intra-articular distal radial fractures. A randomized study. J Bone Joint Surg Am. 2008;90(1):16e22.
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21. Wolfe SW, Swigart CR, Grauer J, Slade JF III, Panjabi MM. Augmented external fixation of distal radius fractures: a biomechanical analysis. J Hand Surg Am. 1998;23(1):127e134. 22. Dunning CE, Lindsay CS, Bicknell RT, Patterson SD, Johnson JA, King GJ. Supplemental pinning improves the stability of external fixation in distal radius fractures during simulated finger and forearm motion. J Hand Surg Am. 1999;24(5):992e1000. 23. Margaliot Z, Haase SC, Kotsis SV, Kim HM, Chung KC. A metaanalysis of outcomes of external fixation versus plate osteosynthesis for unstable distal radius fractures. J Hand Surg Am. 2005;30(6): 1185e1199. 24. Orbay JL, Fernandez DL. Volar fixation for dorsally displaced fractures of the distal radius: a preliminary report. J Hand Surg Am. 2002;27(2):205e215. 25. Kamano M, Koshimune M, Toyama M, Kazuki K. Palmar plating system for Colles’ fractures—a preliminary report. J Hand Surg Am. 2005;30(4):750e755. 26. Chung KC, Watt AJ, Kotsis SV, Margaliot Z, Haase SC, Kim HM. Treatment of unstable distal radial fractures with the volar locking plating system. J Bone Joint Surg Am. 2006;88(12):2687e2694. 27. Rozental TD, Blazar PE. Functional outcome and complications after volar plating for dorsally displaced, unstable fractures of the distal radius. J Hand Surg Am. 2006;31(3):359e365. 28. Jupiter JB, Marent-Huber M. Operative management of distal radial fractures with 2.4-millimeter locking plates. A multicenter prospective case series. J Bone Joint Surg Am. 2009;91(1): 55e65. 29. Arora R, Lutz M, Hennerbichler A, Krappinger D, Espen D, Gabl M. Complications following internal fixation of unstable distal radius fracture with a palmar locking-plate. J Orthop Trauma. 2007;21(5): 316e322. 30. Esenwein P, Sonderegger J, Gruenert J, Ellenrieder B, Tawfik J, Jakubietz M. Complications following palmar plate fixation of distal radius fractures: a review of 665 cases. Arch Orthop Trauma Surg. 2013;133(8):1155e1162. 31. Landgren M, Jerrhag D, Tagil M, Kopylov P, Geijer M, Abramo A. External or internal fixation in the treatment of non-reducible distal radial fractures? Acta Orthop. 2011;82(5):610e613. 32. Williksen JH, Husby T, Hellund JC, Kvernmo HD, Rosales C, Frihagen F. External fixation and adjuvant pins versus volar locking plate fixation in unstable distal radius fractures: a randomized, controlled study with a 5-year follow-up. J Hand Surg Am. 2015;40(7):1333e1340. 33. Klug RA, Press CM, Gonzalez MH. Rupture of the flexor pollicis longus tendon after volar fixed-angle plating of a distal radius fracture: a case report. J Hand Surg Am. 2007;32(7):984e988. 34. Cho CH, Lee KJ, Song KS, Bae KC. Delayed rupture of flexor pollicis longus after volar plating for a distal radius fracture. Clin Orthop Surg. 2012;4(4):325e328. 35. Hudak PL, Amadio PC, Bombardier C. Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med. 1996;29(6):602e608. 36. MacDermid JC, Turgeon T, Richards RS, Beadle M, Roth JH. Patient rating of wrist pain and disability: a reliable and valid measurement tool. J Orthop Trauma. 1998;12(8):577e586. 37. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276(8):637e639. 38. MacDermid JC. Development of a scale for patient rating of wrist pain and disability. J Hand Ther. 1996;9(2):178e183. 39. Atroshi I, Gummesson C, Andersson B, Dahlgren E, Johansson A. The disabilities of the arm, shoulder and hand (DASH) outcome questionnaire: reliability and validity of the Swedish version evaluated in 176 patients. Acta Orthop Scand. 2000;71(6): 613e618. 40. Mellstrand Navarro C, Ponzer S, Tornkvist H, Ahrengart L, Bergström G. Measuring outcome after wrist injury: translation and
4. Rozental TD, Blazar PE, Franko OI, Chacko AT, Earp BE, Day CS. Functional outcomes for unstable distal radial fractures treated with open reduction and internal fixation or closed reduction and percutaneous fixation. A prospective randomized trial. J Bone Joint Surg Am. 2009;91(8):1837e1846. 5. Wei DH, Raizman NM, Bottino CJ, Jobin CM, Strauch RJ, Rosenwasser MP. Unstable distal radial fractures treated with external fixation, a radial column plate, or a volar plate. A prospective randomized trial. J Bone Joint Surg Am. 2009;91(7):1568e1577. 6. Egol K, Walsh M, Tejwani N, McLaurin T, Wynn C, Paksima N. Bridging external fixation and supplementary Kirschner-wire fixation versus volar locked plating for unstable fractures of the distal radius: a randomised, prospective trial. J Bone Joint Surg Br. 2008;90(9): 1214e1221. 7. Grewal R, MacDermid JC, King GJ, Faber KJ. Open reduction internal fixation versus percutaneous pinning with external fixation of distal radius fractures: a prospective, randomized clinical trial. J Hand Surg Am. 2011;36(12):1899e1906. 8. Kreder HJ, Hanel DP, Agel J, et al. Indirect reduction and percutaneous fixation versus open reduction and internal fixation for displaced intra-articular fractures of the distal radius: a randomised, controlled trial. J Bone Joint Surg Br. 2005;87(6):829e836. 9. Kapoor H, Agarwal A, Dhaon BK. Displaced intra-articular fractures of distal radius: a comparative evaluation of results following closed reduction, external fixation and open reduction with internal fixation. Injury. 2000;31(2):75e79. 10. Wilcke MK, Abbaszadegan H, Adolphson PY. Wrist function recovers more rapidly after volar locked plating than after external fixation but the outcomes are similar after 1 year. Acta Orthop. 2011;82(1):76e81. 11. Arora R, Lutz M, Deml C, Krappinger D, Haug L, Gabl M. A prospective randomized trial comparing nonoperative treatment with volar locking plate fixation for displaced and unstable distal radial fractures in patients sixty-five years of age and older. J Bone Joint Surg Am. 93(23):2146e2153. 12. Williksen JH, Frihagen F, Hellund JC, Kvernmo HD, Husby T. Volar locking plates versus external fixation and adjuvant pin fixation in unstable distal radius fractures: a randomized, controlled study. J Hand Surg Am. 2013;38(8):1469e1476. 13. Mellstrand Navarro C, Ahrengart L, Tornqvist H, Ponzer S. Volar locking plate or external fixation with optional addition of K-wires for dorsally displaced distal radius fractures: a randomized controlled study. J Orthop Trauma. 2016;30(4):217e224. 14. Costa ML, Achten J, Parsons NR, et al. Percutaneous fixation with Kirschner wires versus volar locking plate fixation in adults with dorsally displaced fracture of distal radius: randomised controlled trial. BMJ. 2014;349:g4807. 15. Karantana A, Downing ND, Forward DP, et al. Surgical treatment of distal radial fractures with a volar locking plate versus conventional percutaneous methods: a randomized controlled trial. J Bone Joint Surg Am. 2013;95(19):1737e1744. 16. Xie X, Xie X, Qin H, Shen L, Zhang C. Comparison of internal and external fixation of distal radius fractures. Acta Orthop. 2013;84(3): 286e291. 17. Li-hai Z, Ya-nan W, Zhi M, et al. Volar locking plate versus external fixation for the treatment of unstable distal radial fractures: a metaanalysis of randomized controlled trials. J Surg Res. 2015;193(1): 324e333. 18. Walenkamp MM, Bentohami A, Beerekamp MS, et al. Functional outcome in patients with unstable distal radius fractures, volar locking plate versus external fixation: a meta-analysis. Strategies Trauma Limb Reconstr. 2013;8(2):67e75. 19. Zanotti RM, Louis DS. Intra-articular fractures of the distal end of the radius treated with an adjustable fixator system. J Hand Surg Am. 1997;22(3):428e440. 20. Sanders RA, Keppel FL, Waldrop JI. External fixation of distal radial fractures: results and complications. J Hand Surg Am. 1991;16(3): 385e391.
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41.
42.
43.
44.
45.
46.
47.
48. Sarmiento A, Pratt GW, Berry NC, Sinclair WF. Colles’ fractures. Functional bracing in supination. J Bone Joint Surg Am. 1975;57(3): 311e317. 49. Navarro CM, Pettersson HJ, Enocson A. Complications after distal radius fracture surgery: results from a Swedish Nationwide Registry study. J Orthop Trauma. 2015;29(2):E36eE42. 50. Cui Z, Pan J, Yu B, Zhang K, Xiong X. Internal versus external fixation for unstable distal radius fractures: an up-to-date metaanalysis. Int Orthop. 2011;35(9):1333e1341. 51. Diaz-Garcia RJ, Oda T, Shauver MJ, Chung KC. A systematic review of outcomes and complications of treating unstable distal radius fractures in the elderly. J Hand Surg Am. 2011;36(5):824e835.e2. 52. Tubeuf S, Yu G, Achten J, et al. Cost effectiveness of treatment with percutaneous Kirschner wires versus volar locking plate for adult patients with a dorsally displaced fracture of the distal radius: analysis from the DRAFFT trial. Bone Joint J. 2015;97-B(8):1082e1089. 53. Karantana A, Scammell BE, Davis TR, Whynes DK. Costeffectiveness of volar locking plate versus percutaneous fixation for distal radial fractures: economic evaluation alongside a randomised clinical trial. Bone Joint J. 2015;97-B(9):1264e1270. 54. Huetteman HE, Shauver MJ, Nasser JS, Chung KC. The desired role of health care providers in guiding older patients with distal radius fractures: a qualitative analysis. J Hand Surg Am. 2018;43(4): 312e320.e4.
validation of the Swedish version of the patient-rated wrist evaluation (PRWE-Swe). BMC Musculoskelet Disord. 2011;12:171. Roy JS, MacDermid JC, Woodhouse LJ. Measuring shoulder function: a systematic review of four questionnaires. Arthritis Rheum. 2009;61(5):623e632. Walenkamp MM, Vos LM, Strackee SD, Goslings JC, Schep NW. The unstable distal radius fracture—how do we define it? A Systematic Review. J Wrist Surg. 2015;4(4):307e316. The EuroQol Group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3): 199e208. Funfgeld EW. The vigorimeter: for measurement of the strength of the hand and simulation testing [in German]. Dtsch Med Wochensch. 1966;91(49):2214e2216. Knirk JL, Jupiter JB. Intra-articular fractures of the distal end of the radius in young adults. J Bone Joint Surg Am. 1986;68(5): 647e659. Földhazy Z, Ahrengart L. External fixation versus closed treatment of displaced distal radial fractures in elderly patients: a randomized controlled trial. Curr Orthop Pract. 2010;21(3):288e295. Engelberg R, Martin DP, Agel J, Obremsky W, Coronado G, Swiontkowski MF. Musculoskeletal Function Assessment instrument: criterion and construct validity. J Orthop Res. 1996;14(2): 182e192.
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External Fixation Versus Volar Locking Plate for Unstable Dorsally Displaced Distal Radius Fractures—A 3-year Follow-Up of a Randomized Controlled Study Jenny Saving, MD,*† Anders Enocson, MD, PhD,*‡ Sari Ponzer, MD, PhD,*† Cecilia Mellstrand Navarro, MD, PhD*§ Purpose To determine if a volar locking plate (VLP) is superior to external fixation (EF) 3 years after surgery for unstable, dorsally displaced, distal radius fractures caused by lowenergy injury in patients 50 to 74 years of age. Methods During 2009 to 2013, 140 patients with an unstable dorsally displaced distal radius fracture were randomized to either VLP or EF. One hundred eighteen patients (EF 56, VLP 62) were available for a 3-year follow-up. The primary outcome was the Disabilities of the Arm, Shoulder, and Hand score (DASH) at 3 years. Secondary outcomes were Patient-Related Wrist Evaluation score (PRWE), EuroQol-5 Dimensions (EQ-5D) score, range of motion (ROM), grip strength, and radiological signs of osteoarthritis (OA) at 3 years. Moreover, reoperations and minor complications during the first 3 years were recorded. Results There were no differences regarding DASH, PRWE, EQ-5D, ROM or grip strength. The reoperation rate was 21% (13 of 62) in the VLP group compared with 14% (8 of 56) in the EF group. The OA rate was 42% (25 of 59) in the VLP group compared with 28% (15 of 53) in the EF group. Conclusions Three years after surgery for unstable dorsally displaced distal radius fractures, the clinical and radiological results for VLP and EF were comparable. (J Hand Surg Am. 2018;(-):-e-. Copyright Ó 2018 by the American Society for Surgery of the Hand. All rights reserved.) Type of study/level of evidence Therapeutic II. Key words Distal radius fracture, external fixation, randomized controlled study, surgical treatment, volar locking plate.
From the *Department of Clinical Science and Education, Södersjukhuset; the ‡Department of Molecular Medicine and Surgery, Karolinska University Hospital, Karolinska Institutet; the †Department of Orthopaedics; and the §Department of Hand Surgery, Södersjukhuset Hospital, Stockholm, Sweden. Received for publication January 15, 2018; accepted in revised form September 26, 2018. No benefits in any form have been received or will be received related directly or indirectly to the subject of this article. Corresponding author: Jenny Saving, MD, Department of Orthopaedics, Södersjukhuset Hospital, SE—118 83 Stockholm, Sweden; e-mail: [email protected]. 0363-5023/18/---0001$36.00/0 https://doi.org/10.1016/j.jhsa.2018.09.015
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displaced distal radius fractures remains controversial. Several studies report similar 1-year outcomes regardless of the treatment method.1e15 Shortterm results seem to favor surgical treatment with a volar plate over percutaneous methods.10,16e18 External fixation (EF) was introduced as a surgical treatment of distal radius fractures during the 1970s and has proven to give good results.19,20 An EF can be augmented with percutaneous pinning to add stability or to reduce intra-articular fractures.21,22 PTIMAL TREATMENT OF DORSALLY
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Commonly reported complications after EF and pinning are transient superficial nerve palsy, pin track infection, and loss of fracture reduction.19,20 However, severe complications are rare.23 Internal fixation with a volar locking plate (VLP) was introduced during the 1990s with good clinical and radiological results.24e28 It allows earlier movement of the wrist, which seems to be beneficial for earlier return of function. Common complications are median nerve palsy, flexor tenosynovitis, extensor tenosynovitis, and tendon rupture.29 In addition, 15% to 30% of all volar plates are removed within the first 1 to 2 years according to several studies.11,12,29,30 Few studies compare results beyond 1 year after distal radius fracture surgery. The total rate of complications seems to be similar after external fixation and VLPs, but VLPs have been associated with more complications requiring late secondary surgery.6,13,17,31,32 There are reports that secondary surgery occurs 2 to 7 years after fracture surgery,13,31e34 which makes long-term follow-up important, especially for patients treated with internal fixation left in place that may cause mechanical attrition of surrounding soft tissues. The purpose of this study was to perform a 3-year follow-up of patients aged 50 to 74 years, treated within the context of a randomized controlled trial comparing EF and VLP for dorsally displaced distal radius fractures caused by a low-energy injury. The primary aim was to investigate the null hypothesis that VLP is equal to EF 3 years after surgery in terms of the Disabilities of the Arm, Shoulder, and Hand (DASH) score.35 Secondary aims were to compare the outcome regarding the Patient-Rated Wrist Evaluation (PRWE) score,36 health-related quality of life, grip strength, range of motion (ROM), radiographic signs of osteoarthritis (OA), and complications.
proximal to the extensor pollicis longus muscle. The extensor carpi radialis longus and brevis tendons were retracted, and the radius was exposed for the application of 2 threaded 3-mm pins. Dorsolaterally, on the second metacarpal bone, 2 threaded 3-mm pins were introduced through stab incisions. The external fixator was attached, and the fracture was reduced under fluoroscopic control by means of ligamentotaxis. Additional 1.6-mm Kirschner wires were applied at the surgeon’s discretion. The external fixator and Kirschner wires were extracted at an outpatient office visit 5 to 6 weeks after surgery. The VLP fixation was performed via a straight incision over the flexor carpi radialis tendon, which was retracted ulnarly. The flexor tendon sheath was opened and the flexor pollicis longus tendon was held with retractors ulnarly. The pronator quadratus muscle was split and the fracture was exposed and reduced under fluoroscopic control. Fracture stabilization was achieved by applying a VLP proximal to the watershed line. Repair of the pronator quadratus was based on the judgment of the operating surgeon. The wrist was immobilized in a dorsal plaster orthosis for 4 weeks to diminish postoperative pain. All patients were encouraged to perform finger ROM exercises immediately after the surgical procedure. After removing the plaster orthosis or external fixator and any additional pins, all patients were referred to the occupational therapists in our department for standard rehabilitation. Results of the 1-year follow-up have been reported previously.13 In total, 134 (96%) patients, 65 in the EF group and 69 in the VLP group, completed the 1year follow-up. They were all contacted by mail and telephone and asked to participate in a 3-year followup, and 118 (84%) patients agreed to participate: 56 in the EF group and 62 in the VLP group (Fig. 1). Nine patients in the EF group declined to participate including 1 patient who had 3 reoperations: volar plate fixation owing to fracture redisplacement, carpal tunnel release, and plate extraction owing to flexor tenosynovitis. Seven patients in the VLP group declined to participate of whom 1 patient had been reoperated with plate extraction owing to flexor tenosynovitis. The study was registered at www.clinicaltrials.gov (NCT01034943, NCT01035359). The protocol was set up according to the Consolidated Standards of Reporting Trials (CONSORT) guidelines37 and conformed to the ethical guidelines of the 1975 Declaration of Helsinki. Written informed consent was obtained from each patient. The study was approved by the Regional Ethical Review Board in Stockholm, Sweden, reference number 2012/1127-32.
METHODS In an earlier published study13 conducted at Södersjukhuset Hospital, Stockholm, Sweden, during September 2009 to February 2013, 140 patients with dorsally displaced distal radius fractures were prospectively randomized to surgery with either EF (Hoffman Compact T2; Stryker, Amsterdam, the Netherlands) with or without additional pinning (n ¼ 70), or VLP fixation (2.4-mm Variable Angle LCP Two-Column Volar Distal Radius Plate; Synthes, Zuchwil, Switzerland) (n ¼ 70). Inclusion and exclusion criteria are presented in Table 1. The external fixator was applied using a 4-cm dorsolateral incision J Hand Surg Am.
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was graded according to the scale of Knirk and Jupiter (0e3)45 and in the distal radioulnar joint (DRUJ) as present or not.
TABLE 1. Inclusion and Exclusion Criteria for Patients With Distal Radius Fracture for Selection to a Randomized Controlled Trial Comparing VLP and EF
Complications: Patients underwent a clinical examination for detection of complications. Moreover, patients were interviewed, and all patient records were investigated. All signs of complications prevailing at 3 years after surgery and all complications causing a reoperation were reported. Removal of external fixation was not considered a reoperation.
Inclusion Criteria Patient age (50e74 y for women and 60e74 y for men) Injury only after fall from standing height Wrist radiography of > 20 dorsal angulation and/or > 5 mm axial shortening (OTA class 23 A2, A3, C1, C2, C3) Good knowledge of written and spoken Swedish Fracture diagnosed within 72 h
Statistics: All results are presented according to the intention-to-treat principle. An a priori power calculation was performed to detect a 10-point difference in DASH 1 year after surgery at an 80% power level with a presumed SD of 20.46 The cohort needed was 64 patients in each group. The cohort available for the 3 years of follow-up was 53 and 59 patients, respectively, which makes our study underpowered for comparisons of primary and secondary outcomes. Level of significance was set to P less than .05 in 2-sided tests. Student t test was used for comparisons of means. Results are presented as the means with corresponding SDs and confidence intervals. Chi-square tests were performed for comparisons of proportions. Fisher exact test was used for comparison of proportions when expected numbers were less than 5 in any 1 cell of the contingency tables. Linear regression was performed to investigate any correlation between OA and clinical outcome.
Patient resident within the catchment area of the hospital Exclusion Criteria Former disability of either wrist Other concomitant injuries Rheumatoid arthritis or other severe joint disorder Dementia or Pfeiffer score* < 5 Drug or alcohol abuse or psychiatric disorder Dependency in activities of daily living Medical condition contraindicating general anesthesia OTA, Orthopaedic Trauma Association. *Adapted from Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatric Soc. 1975;23(10):433e441.
Outcome variables Patient-Reported Outcome Measures: The DASH score was the primary outcome.35 The PRWE score was investigated as a secondary outcome.36 Both scores are validated for the evaluation of distal radius fractures35,38 and translated and validated for use in Swedish.39,40 Both scores range from 0, which indicates no disability, to 100, which indicates maximum disability. The minimal clinically important difference for the DASH is considered to be 10 points41 and for the PRWE 11.5 points.42 Health-related quality of life was assessed by the EuroQol-5 Dimensions (EQ-5D) score.43 The score ranges from 0, which indicates the worst possible state, to 1, which indicates the best possible state of health-related quality of life.
RESULTS In total, 118 patients filled in the Patient-Reported Outcome Measures (PROM) questionnaires of whom 112 patients (53 in the EF group and 59 in the VLP group) also completed all clinical and radiological investigations. The 6 patients who filled in all questionnaires but did not participate in clinical and radiological evaluation gave their consent to medical record investigation. The mean follow-up time was 37 months (range, 34e48 months). Patient characteristics at baseline are presented in Table 2.
Grip strength and ROM: An independent occupational therapist investigated ROM and grip strength in the injured and uninjured extremity. Grip strength was measured using a Martin vigorimeter.44 The ROM and grip strength are presented as percentages of the uninjured side. Grip strength was not corrected for hand dominance, as suggested by Margaliot et al.23
PROMs There were no differences in PRWE, DASH, or EQ5D between the groups (Table 3). Between 1 year and 3 years, there were statistically significant improvements of equal size within each group for DASH (EF, 11.5 to 7.0; 95% confidence interval [95% CI, 2.3e6.8]; VLP, 10.5 to 5.4; 95%
Radiological evaluation: An independent radiologist investigated signs of OA. In the radiocarpal joint, it J Hand Surg Am.
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Eligible paƟents (n = 1349) Excluded Not meeƟng the inclusion criteria (n = 1055) No trial consultant or research nurse available (n = 86) Declined to parƟcipate (n = 51)
Randomized (n = 140)
Allocated to external fixaƟon (n = 70) Received allocated intervenƟon (n = 66) Did not receive allocated intervenƟon (surgeon´s choice) (n = 4)
Allocated to volar plate (n = 70) Received allocated intervenƟon (n = 70)
Exclusion due to not meeƟng inclusion criteria (n = 1) n = 69
Follow-up 2 weeks
n = 67
Follow-up 3 months
n = 70
Lost to follow-up Death (n = 1) Declined to parƟcipate (n = 1)
n = 70
Lost to follow-up Declined to parƟcipate (n = 1) No answer (n = 1)
Lost to follow up Declined to parƟcipate (n = 1)
n = 65
Follow-up 1 year
Lost to follow up Declined to parƟcipate (n = 9)
n = 69
Lost to follow up Declined to parƟcipate (n = 7)
n = 56 53 paƟents completed all variables For 3 paƟents only DASH, PRWE, and EQ-5D outcomes were recorded
Follow-up 3 years
n = 62 59 paƟents completed all variables For 3 paƟents only DASH, PRWE, and EQ-5D outcomes were recorded
FIGURE 1: Flow chart for inclusion of patients with distal radius fracture to a randomized controlled study comparing VLP and EF.
Radiological outcome There was no difference in radiological signs of OA in the radiocarpal or DRUJ; 42% (25 of 59) in the VLP group compared with 28% (15 of 53) in the EF group. Osteoarthritis was not correlated to clinical outcome as expressed by DASH. The study size was not large enough to make any statistical inferences regarding radiological outcome.
CI, 2.3e8.0) and PRWE (EF, 12.4 to 6.6; 95% CI, 3.0e8.5; VLP, 12.7 to 6.1; 95% CI, 3.3e9.9). However, these improvements did not reach the minimal clinically important difference. Grip strength and ROM There were no statistically significant differences in grip strength or ROM between groups (Table 4). Between 1 year and 3 years, there were improvements in grip strength in the EF group from 82% to 90% (95% CI, 3.4 to 12.6), and in the VLP group from 87% to 102%, (95% CI, e0.4 to 32.3). J Hand Surg Am.
Complications Twenty-one percent (13 of 62) of the patients in the VLP group compared with 14% (8 of 56) in the EF r
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patients were younger (mean, 42 years) than in our study and they included only intra-articular fractures. Furthermore, all dorsal plates were routinely removed after 6 months to avoid tendon attrition. As most studies report similar functional results regardless of surgical method at 1 year or later,1e10,12e15,31,32 it is important to consider the burden of complications. There were more reoperations (although not statistically significant) in the VLP group (13 patients) than in the EF group (8 patients) in our study, and most of the reoperations in the VLP group consisted of plate extraction owing to tendon or nerve symptoms: 11 of the plates were extracted in the VLP group and 5 of them were removed later than 1 year after initial surgery. Williksen et al32 reported a 31% (16 of 52) reoperation rate in the VLP group compared with 17% (10 of 59) in the EF group 5 years after initial surgery. In their study, 11 out of 52 plates were removed and 3 of them were taken out after the first year. Landgren et al31 reported a reoperation rate of 54% (14 of 26) in VLP patients compared with 41% (10 of 24) in EF patients 5 years after initial surgery. In the VLP group, 12 out of 26 plates were extracted. Esenwein et al30 examined 665 patients operated with VLP up to 2 years after surgery and had a reoperation rate of 10%. They reported 232 of 665 (35%) plate extractions but did not consider plate extraction as a complication. Because complications are relatively rare, larger study populations are needed to detect possible differences between groups. Our study was not powered to determine true differences between groups regarding complications. In a registry study from Sweden with 36,618 patients, there were significantly more reoperations for VLP patients than for EF patients.49 Furthermore, reoperations for EF patients occurred early and consisted mainly of secondary plate fixation owing to fracture displacement. Reoperations for VLP patients occurred late and consisted mainly of plate extractions. Registry studies are an efficient study design for detecting rare events in large patient populations, such as reoperations after wrist fracture surgery. An obvious problem, however, is that no control can be made for biases such as different case mixes with varying fracture severity. Large prospective controlled cohorts and/or multicenter trials with long-term follow-up are also needed to further elucidate complications after distal radius fracture surgery. There were significantly more scar adherences at 3 years in the EF group than in the VLP group. To our knowledge, there are no published long-term presentations of mild complications such as this, but
TABLE 2. Baseline Data at Inclusion for Patients Treated for Unstable Dorsally Displaced Distal Radius Fracture With External Fixation or VLP Available at 3-Y Follow-Up EF Group (n ¼ 56)
VLP Group (n ¼ 62)
Mean age, y (range)
63 (50e74)
63 (51e74)
Number of females
54 (96%)
55 (89%)
Number with injury to dominant hand
30 (54%)
23 (37%)
7 (13%)
10 (16%)
Smoker OTA classification A2
4 (7%)
3 (5%)
A3
15 (27%)
21 (34%)
C1
31 (55%)
33 (53%)
C2
4 (7%)
3 (5%)
C3
2 (4%)
2 (3%)
OTA, Orthopaedic Trauma Association.
group had had 1 or more reoperations. The study size was not large enough to make any statistical inferences regarding complications. All reoperations are presented in Table 5. In the VLP group, 11 of 62 patients had their plate removed. Five of these implant removals occurred during the second or third year after fracture, 4 owing to extensor tenosynovitis, and 1 owing to flexor tenosynovitis. Eight percent (5 of 59) of the patients in the VLP group compared with 60% (32 of 53) in the EF group had scar adherence. Minor nerve symptoms were present in 8% (4 of 53) of the EF patients compared with 3% (2 of 59) of the VLP patients. DISCUSSION The main finding of this study was that, 3 years after surgery for dorsally displaced distal radius fractures after low-energy trauma, neither DASH nor any of the other clinical or radiological outcomes differed between patients treated with EF or VLP. Our findings are supported by several other authors. Williksen et al32 reported no significant difference in DASH between EF and VLP after 5 years. Landgren et al31 found no difference in DASH between EF and fragment-specific plating after 5 years. Kreder et al8 found no difference in Musculoskeletal Functional Assessment score47 between EF and plating after 2 years. In contrast, Leung et al3 reported a better Gartland and Werley score48 2 years after surgery with volar and/or dorsal plates compared with EF, but the J Hand Surg Am.
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TABLE 3. PROM in Patients Treated for Unstable Dorsally Displaced Distal Radius Fracture With EF or VLP Available for 3-Year Follow-Up EF Group (n ¼ 56)
VLP Group (n ¼ 62)
Mean Difference
Mean DASH (SD)
7.0 (9.9)
5.4 (7.1)
1.6
Mean PRWE (SD)
6.6 (12.0)
6.1 (9.2)
0.5
e3.4 to 4.4
Mean EQ-5D (SD)
0.92 (0.13)
0.92 (0.13)
0.00
e0.04 to 0.05
95% CI e1.6 to 4.8
TABLE 4. Grip Strength and ROM in Patients Treated for Unstable Dorsally Displaced Distal Radius Fracture With EF or VLP Available for 3-Year Follow-Up EF Group (n ¼ 53)
VLP Group (n ¼ 59)
Mean Difference
Mean grip strength as % of uninjured wrist (SD)
90 (16)
102 (59)
12
e4.5 to 28.7
Mean dorsal extension as % of uninjured wrist (SD)
94 (12)
97 (14)
3
e2.5 to 7.5
Mean volar flexion as % of uninjured wrist (IQR)
89 (10)
93 (14)
4
e1.0 to 8.5
Mean radial deviation as % of uninjured wrist (IQR)
94 (11)
100 (13)
6
Mean ulnar deviation as % of uninjured wrist (IQR)
102 (15)
99 (13)
3
e2.6 to 7.9
Mean supination as % of uninjured wrist (IQR)
96 (8)
95 (11)
1
e3.0 to 4.0
Mean pronation as % of uninjured wrist (IQR)
100 (8)
99 (7)
1
e1.6 to 4.1
95% CI
0.9 to 10.0
IQR, interquartile range.
affect the long-term outcome. Based on these findings, other factors than final clinical outcome may influence treatment choices. In a setting with limited health care resources, cost-effective health care utilization is important. Tubeuf and colleagues52 evaluated the cost-effectiveness of operative treatment with plate fixation compared with operative treatment with percutaneous fixation (Kirschner wires) over a time perspective of 12 months. The analysis showed that plating was not cost-effective compared with treatment with K-wires in any age group. Another costeffectiveness study from Karantana et al53 reported that volar plating was not cost-effective compared with percutaneous treatments. A majority of patients in any fracture surgery practice may be opposed to the idea of an external fixation because of the appearance of the fixation device compared with internal fixation, regardless of equal clinical results in outcome studies. There may exist a difference in cultural acceptance in different areas of the world. Some patients may oppose carrying internal metalwork in their body and would,
there is supporting evidence of more complications that do not require surgery after EF compared with VLP.50,51 There were more patients with radiological signs of OA in the VLP group than in the EF group. This finding conflicts with the 2-year results of Leung et al,3 who showed that more OA was found among EF patients than among plated patients. An explanation for our findings could be that the plating procedure per se is putting the patient at risk for OA owing to the invasive nature of the surgical method. In our study, radiological evaluation took place of both the radiocarpal and the DRUJ, which may have caused a higher rate of OA compared with other studies. Jupiter and Marent-Huber28 evaluated a cohort of VLP patients and found a radiological radiocarpal OA rate of 27%, which is similar to our study. Unfortunately, our study is not large enough to ensure that our finding regarding OA is not a product of chance. Our study showed that the choice of surgical method for a distal radius fracture did not substantially J Hand Surg Am.
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EXTERNAL FIXATION VERSUS VOLAR PLATE, 3 YEARS
TABLE 5. Reoperations in Patients With Unstable Dorsally Displaced Distal Radial Fractures Treated With EF or VLP at 3-Year Follow-Up Reoperation Secondary plating owing to fracture redisplacement
EF Group (n ¼ 56)
VLP Group (n ¼ 62)
3
2
Plate extraction Tenosynovitis
2*
8
Complex regional pain syndrome
0
1
Other Fasciotomy owing to compartment syndrome
0
2
0
1
Carpal tunnel release
1
1
Debridement owing to deep infection
1
0
Scar correction
2
0
Tendon transfer owing to extensor tendon rupture
0
1
Total
9†
16‡
*Converted during surgery to VLP or secondary plating owing to fracture redisplacement. †One patient had 2 reoperations—secondary plating owing to fracture redisplacement and subsequent plate extraction. ‡Three patients had 2 reoperations—1 had secondary plating owing to fracture redisplacement and subsequent plate extraction, 1 had fasciotomy owing to compartment syndrome and subsequent plate extraction, and 1 had carpal tunnel release and subsequent plate extraction.
if offered, choose fixation where no hardware is left after fracture healing. Obviously, plate removal would solve this matter but that would involve higher treatment costs and risks for surgical complications. No study has been performed investigating patients’ own experiences of radius fracture treatments, and there is a paucity of published data regarding any qualitative matter in fracture surgery. In a recently published qualitative study of patients treated for a distal radius fracture, Huetteman et al54 found that most patients prefer shared decision making regarding choice of treatment. It should be of interest for future clinicians and researchers to investigate patients’ personal opinions, experiences, and preferences and include those factors in the decision making regarding distal radius fracture care. One limitation of our study was that 12% of patients did not complete the 3-year follow-up. We do not know the reasons why these patients refused the follow-up, but we do not believe that the difference in loss to follow-up affects the overall findings of our study. Because of the dropouts, we did not reach the number of 64 patients in each arm that we calculated in our power estimation. Furthermore, neither patients nor investigators were blinded to the intervention and we did not perform any inter- or intraobserver validity testing for our radiological interpretation. Our study has several strengths. It is a large cohort of randomized patients in a homogeneous study population. All data were prospectively collected, and patient records were checked for accuracy according to J Hand Surg Am.
the study protocols. Our study has a 3-year follow-up and is, therefore, 1 of very few studies that report a comparison of clinical results, PROMs, and complication rate for EF and VLP beyond a 1-year follow-up. In conclusion the clinical and radiological outcome was comparable after VLP and EF 3 years after surgery for unstable, dorsally displaced distal radius fractures caused by low-energy trauma in patients aged 50 to 74 years. Volar plating might be associated with more reoperations than EF. More and larger studies of long-term results after distal radius fracture surgery are warranted. ACKNOWLEDGMENTS This study was conducted with funding by the Swedish Research Council and the Regional Agreement on Medical Training and Clinical Research between the Stockholm County Council and Karolinska Institutet (ALF). REFERENCES 1. Abramo A, Kopylov P, Geijer M, Tagil M. Open reduction and internal fixation compared to closed reduction and external fixation in distal radial fractures: a randomized study of 50 patients. Acta Orthop. 2009;80(4):478e485. 2. Xu GG, Chan SP, Puhaindran ME, Chew WY. Prospective randomised study of intra-articular fractures of the distal radius: comparison between external fixation and plate fixation. Ann Acad Med Singapore. 2009;38(7):600e606. 3. Leung F, Tu YK, Chew WY, Chow SP. Comparison of external and percutaneous pin fixation with plate fixation for intra-articular distal radial fractures. A randomized study. J Bone Joint Surg Am. 2008;90(1):16e22.
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