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Randomized Controlled Trial
. 2020 Jun;145(6):1054e-1066e.
doi: 10.1097/PRS.0000000000006829.

The Wrist and Radius Injury Surgical Trial: 12-Month Outcomes from a Multicenter International Randomized Clinical Trial

Kevin C Chung  1 , H Myra Kim  1 , Sunitha Malay  1 , Melissa J Shauver  1 ; Wrist and Radius Injury Surgical Trial Group
Affiliations
Randomized Controlled Trial

The Wrist and Radius Injury Surgical Trial: 12-Month Outcomes from a Multicenter International Randomized Clinical Trial

Kevin C Chung et al. Plast Reconstr Surg. 2020 Jun.

Abstract

Background: Optimal treatment for distal radius fractures in older adults remains uncertain. No randomized trials comparing the most frequently used treatments in this population have been conducted. Surgical treatment rates vary widely, and the sustained benefits of surgery are uncertain.

Methods: The Wrist and Radius Injury Surgical Trial, a randomized, multicenter trial, enrolled 304 adults aged 60 years and older with isolated, unstable distal radius fractures at 24 institutions. Patients who wanted surgery (n = 187) were randomized to internal fixation, external fixation, or percutaneous pinning; patients who preferred conservative management (n = 117) received casting. The primary outcome was the 12-month Michigan Hand Outcomes Questionnaire (MHQ) summary score.

Results: At 12 months, there were no differences by treatment in primary outcome. Twelve-month MHQ summary scores differed between internal fixation and external fixation by 3 points (97.5 percent CI, 6.0 to 11.5) and between internal fixation and pinning by -0.14 (97.5 percent CI, -9.2 to 8.9). However, at 6 weeks, the mean MHQ summary score for internal fixation was greater than for external fixation by 19 (p < 0.001), pinning by 11 (p < 0.001), and casting by 7 (p = 0.03). Internal fixation participants demonstrated significantly better radiologic alignment throughout the follow-up period. Malunion was experienced by 48 percent of casting participants.

Conclusions: Recovery was fastest for internal fixation and slowest for external fixation according to most measures, but by 12 months there were no meaningful differences in outcomes. Casting participants experienced satisfactory results despite loss of radiologic alignment.

Clinical question/level of evidence: Therapeutic, II.

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Figures

Figure 1.
Figure 1.. CONSORT Diagram
*ineligible fractures include non-displaced fractures, open fractures, and those that are not amenable to treatment with all three surgical methods. **Non-community dwelling patients include those who reside in a nursing home or other institutional setting. *** These were cases where the patient was too anxious, upset, or angry for the surgeon to feel comfortable broaching the subject of a clinical trial or other circumstances where the surgeon felt for some other reason that discussing the trial was inappropriate.
Figure 2:
Figure 2:
a: Unadjusted mean MHQ Summary score by study arm; b: Unadjusted mean MHQ Pain score by study arm
See this image and copyright information in PMC

References

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