Dataset Information

Surgical Plating vs Closed Reduction for Fractures in the Distal Radius in Older Patients: A Randomized Clinical Trial.

ABSTRACT:

Importance

The burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence.

Objective

To assess whether current surgical treatment for displaced distal radius fractures provided better patient-reported wrist pain and function than nonsurgical treatment in patients 60 years and older.

Design, setting, and participants

In this multicenter randomized clinical trial and parallel observational study, 300 eligible patients were screened from 19 centers in Australia and New Zealand from December 1, 2016, until December 31, 2018. A total of 166 participants were randomized to surgical or nonsurgical treatment and followed up at 3 and 12 months by blinded assessors. Those 134 individuals who declined randomization were included in a parallel observational cohort with the same treatment options and follow-up. The primary analysis was intention to treat; sensitivity analyses included as-treated and per-protocol analyses.

Intervention

Surgical treatment was open reduction and internal fixation using a volar-locking plate (VLP). Nonsurgical treatment was closed reduction and cast immobilization (CR).

Main outcomes and measures

The primary outcome was the Patient-Rated Wrist Evaluation score at 12 months. Secondary outcomes were Disabilities of Arm, Shoulder, and Hand questionnaire score, health-related quality of life, pain, major complications, patient-reported treatment success, bother with appearance, and therapy use.

Results

In the 300 study participants (mean [SD] age, 71.2 [7.5] years; 269 [90%] female; 166 [81 VLP and 85 CR] in the randomized clinical trial sample and 134 [32 VLP and 102 CR] in the observational sample), no clinically important between-group difference in 12-month Patient-Rated Wrist Evaluation scores (mean [SD] score of 19.8 [21.1] for VLP and 21.5 [24.3] for CR; mean difference, 1.7 points; 95% CI -5.4 to 8.8) was observed. No clinically important differences were found in quality of life, wrist pain, or bother at 3 and 12 months. No significant difference was found in total complications between groups (12 of 84 [14%] for the CR group vs 6 of 80 [8%] for the VLP group; risk ratio [RR], 0.53; 95% CI, 0.21-1.33). Patient-reported treatment success favored the VLP group at 12 months (very successful or successful: 70 [89%] vs 57 [70%]; RR, 1.26; 95% CI, 1.07-1.48; P = .005). There was greater use of postoperative physical therapy in the VLP group (56 [72%] vs 44 [54%]; RR, 1.32; 95% CI, 1.04-1.69; P = 0.02).

Conclusions and relevance

This randomized clinical trial found no between-group differences in improvement in wrist pain or function at 12 months from VLP fixation over CR for displaced distal radius fractures in older people.

Trial registration

http://anzctr.org.au identifier: ACTRN12616000969460.

SUBMITTER: Combined Randomised and Observational Study of Surgery for Fractures in the Distal Radius in the Elderly (CROSSFIRE) Study Group

PROVIDER: S-EPMC7807386 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundPrimary aim: to compare complications of operative vs non-operative treatment of unstable distal radius fractures (DRF) fulfilling national clinical guidelines for operative treatment. Secondary aim: to compare the functional outcomes.Materials and methodsA single-centre randomized controlled trial of unstable DRF. 50 patients: volar locking plate, 2 weeks casting + 3 weeks orthosis. 50 patients: 5 weeks casting.Primary outcomecomplications assessed after 2 and 5 weeks and 6 and 12 months.Secondary outcomesQuick-DASH, PRWHE, range of motion, grip strength, EQ-5D-3L.Results148 patients were screened from November 2019 to March 2021. 48 patients did not want to participate or were unable to participate in the follow-up. 100 patients were randomized and 85 patients were available for full analysis due to there being 4 deaths, 6 withdrawals, 1 wrong inclusion, 1 emigration, 1 refracture, 1 patient with compartment syndrome, and 1 who was advised to undergo surgery after being randomized to non-operative treatment. Median age was 74 years (range 65-92), 81 women/19 men, 42 right/58 left side, 87 retired, 11 smokers, 86 ASA class 1 or 2. Complication rates did not statistical significantly vary between the operative and non-operative group: 20.9% (9/43) vs 16.6% (7/42), p = 0.78 (Fisher's exact test). Complications were driven by sensory disturbances. Four reoperations were performed: two in the non-operative group: carpal tunnel syndrome; two in the operative group: one carpal tunnel syndrome, one protruding screw causing extensor tendon irritation. Mean difference in Quick-DASH varied from 2.3 (95% CI - 3 to 8) pre-injury to 4.2 (- 4 to 12) at 12 months. Quick-DASH and PRWHE were neither statistically nor clinically-relevant different between groups.ConclusionsComplication rates after operative and non-operative treatment of DRF were similar. Volar plating did not improve the functional outcome after 5 weeks, 6 months, and 12 months. These findings are in line with recent RCTs and mandate a revision of guidelines towards more conservative treatment.Take home messages(1) consider non-operative treatment in elderly patients sustaining unstable DRFs; (2) choosing operative treatment in patients older than 65 years should not be the gold standard; (3) however, non-operative treatment still carries a risk for complications.Level of evidenceII. Trial registration Clinicaltrials.gov NCT03716661, registered 23rd Oct 2018; Published protocol PMC6599306.

Project description:ImportanceTo date, there is currently no evidence-based medical support for the efficacy of topology-optimized splints in treating distal radius fractures.ObjectiveTo assess the clinical efficacy and complication rates of topology-optimized splints in the treatment of distal radius fractures after closed manual reduction.Design, setting, and participantsThis 12-week, multicenter, open-label, analyst-blinded randomized clinical trial (comprising a 6-week intervention followed by a 6-week observational phase) was carried out from December 3, 2021, to March 10, 2023, among 110 participants with distal radius fractures. Statistical analysis was performed on an intention-to-treat basis between June 3 and 30, 2023.InterventionParticipants were randomly assigned to 2 groups: the intervention group received topology-optimized splint immobilization and the control group received cast immobilization after closed manual reduction for 6weeks. After this period, immobilization was removed, and wrist rehabilitation activities commenced.Main outcomes and measuresThe primary outcome was the Gartland-Werley (G-W) wrist score at 6 weeks (where higher scores indicate more severe wrist dysfunction). Secondary outcomes encompassed radiographic parameters, visual analog scale scores, swelling degree grade, complication rates, and 3 dimensions of G-W wrist scores.ResultsA total of 110 patients (mean [SD] age, 64.1 [12.7] years; 89 women [81%]) enrolled in the clinical trial, and complete outcome measurements were obtained for 101 patients (92%). Median G-W scores at 6 weeks were 15 (IQR, 13-18) for the splint group and 17 (IQR, 13-18) for the cast group (mean difference, -2.0 [95% CI, -3.4 to -0.6]; P = .03), indicating a statistically significant advantage for the splint group. At 12 weeks, no clinically significant differences in G-W scores between the 2 groups were observed. Complication rates, including shoulder-elbow pain and dysfunction and skin irritation, were less common in the splint group (shoulder-elbow pain and dysfunction: risk ratio, 0.28 [95% CI, 0.08-0.93]; P = .03; skin irritation: risk ratio, 0.30 [95% CI, 0.10-0.89]; P = .02).Conclusions and relevanceFindings of this randomized clinical trial suggest that patients with distal radius fractures that were managed with topology-optimized splints had better wrist functional outcomes and fewer complications at 6 weeks compared with those who received casting, with no difference at week 12. Therefore, topology-optimized splints with improved performance have the potential to be an advisable approach in the management of distal radius fractures.Trial registrationChinese Clinical Trial Registry: ChiCTR2000036480.