Project description:ImportanceThe burden of injury and costs of wrist fractures are substantial. Surgical treatment became popular without strong supporting evidence.ObjectiveTo 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 participantsIn 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.InterventionSurgical 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 measuresThe 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.ResultsIn 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 relevanceThis 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 registrationhttp://anzctr.org.au identifier: ACTRN12616000969460.

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.

Project description:PurposeDisplaced distal radius fractures in children are common and often treated by reduction and cast immobilization. Redisplacement occurs frequently and may be prevented by additional treatment with K-wire fixation after initial reduction. This meta-analysis aims to summarize available literature on this topic and determine if primary K-wire fixation is the preferred treatment for displaced distal radius fractures in children.MethodsA search in eight databases identified studies that compared cast immobilization alone to additional K-wire fixation as treatment for displaced paediatric distal radius fractures. The primary outcome was the redisplacement rate. Secondary outcomes were secondary reduction rate, range of motion and complications. This meta-analysis was performed according to the preferred reporting items for systematic reviews and meta-analysis (PRISMA) statement.ResultsThree RCTs and 3 cohort studies, analysing 197 patients treated with cast immobilization alone and 185 with additional K-wire fixation, were included in this meta-analysis. Redisplacement occurred less frequently after additional K-wire fixation than after cast alone (3.8 versus 45.7%; OR 0.07, 95% CI 0.03-0.15). Secondary reduction was performed in 59.8% of the redisplaced fractures. Complications, other than redisplacement, occurred more often after additional K-wire fixation than after cast alone (15.7 versus 3.6%). Range of motion did not differ after both treatments.ConclusionsAdditional K-wire fixation is a suitable treatment to prevent redisplacement and secondary operations after initial reduction of displaced distal radius fractures in children, but is associated with post-procedural complications. Additional K-wire fixation does not result in a better range of motion than cast immobilization alone. More research is needed to identify those patients who will benefit the most from K-wire fixation as a treatment for displaced distal radius fractures in children.

Project description:ImportanceNo consensus has been reached to date regarding the optimal treatment for distal radius fractures. The international rate of operative treatment has been increasing, despite higher costs and limited functional outcome evidence to support this shift.ObjectivesTo compare functional, clinical, and radiologic outcomes after operative vs nonoperative treatment of distal radius fractures in adults.Data sourcesThe PubMed/MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched from inception to June 15, 2019, for studies comparing operative vs nonoperative treatment of distal radius fractures.Study selectionRandomized clinical trials (RCTs) and observational studies reporting on the following: acute distal radius fracture with operative treatment (internal or external fixation) vs nonoperative treatment (cast immobilization, splinting, or bracing); patients 18 years or older; and functional outcome. Studies in a language other than English or reporting treatment for refracture were excluded.Data extraction and synthesisData extraction was performed independently by 2 reviewers. Effect estimates were pooled using random-effects models and presented as risk ratios (RRs) or mean differences (MDs) with 95% CIs. Data were analyzed in September 2019.Main outcomes and measuresThe primary outcome measures included medium-term functional outcome measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) and the overall complication rate after operative and nonoperative treatment.ResultsA total of 23 unique studies were included, consisting of 8 RCTs and 15 observational studies, that described 2254 unique patients. Among the studies that presented sex data, 1769 patients were women [80.6%]. Overall weighted mean age was 67 [range, 22-90] years). The RCTs included 656 patients (29.1%); observational studies, 1598 patients (70.9%). The overall pooled effect estimates the showed a significant improvement in medium-term (≤1 year) DASH score after operative treatment compared with nonoperative treatment (MD, -5.22 [95% CI, -8.87 to -1.57]; P = .005; I2 = 84%). No difference in complication rate was observed (RR, 1.03 [95% CI, 0.69-1.55]; P = .87; I2 = 62%). A significant improvement in grip strength was noted after operative treatment, measured in kilograms (MD, 2.73 [95% CI, 0.15-5.32]; P = .04; I2 = 79%) and as a percentage of the unaffected side (MD, 8.21 [95% CI, 2.26-14.15]; P = .007; I2 = 76%). No improvement in medium-term DASH score was found in the subgroup of studies that only included patients 60 years or older (MD, -0.98 [95% CI, -3.52 to 1.57]; P = .45; I2 = 34%]), compared with a larger improvement in medium-term DASH score after operative treatment in the other studies that included patients 18 years or older (MD, -7.50 [95% CI, -12.40 to -2.60]; P = .003; I2 = 77%); the difference between these subgroups was statically significant (test for subgroup differences, P = .02).Conclusions and relevanceThis meta-analysis suggests that operative treatment of distal radius fractures improves the medium-term DASH score and grip strength compared with nonoperative treatment in adults, with no difference in overall complication rate. The findings suggest that operative treatment might be more effective and have a greater effect on the health and well-being of younger, nonelderly patients.

Project description:IntroductionThe aim of this systematic review and meta-analysis was to evaluate whether volar locking plate (VLP) fixation leads to better clinical and radiological outcomes than those of closed reduction and cast immobilization for the treatment of distal radius fractures (DRFs).Materials and methodsA comprehensive literature search was performed in PubMed, Web of Science, and Cochrane databases up to January 2022. Inclusion criteria included randomized controlled trial (RCT) studies comparing VLP fixation with cast immobilization for DRFs. Investigated parameters were Patient-Rated Wrist Evaluation questionnaire, Disabilities of the Harm, Shoulder, and Hand score (DASH), range of motion (ROM), grip strength, quality of life (QoL), radiological outcome, and complication and reoperation rate, both at short- and mid-/long-term follow-up. Assessment of risk of bias and quality of evidence was performed with Downs and Black's 'Checklist for Measuring Quality'.ResultsA total of 12 RCTs (1368 patients) were included. No difference was found for ROM, grip strength, QoL, and reoperation, while the DASH at 3 months was statistically better in the VLP group (P < 0.05). No clinical differences were confirmed at longer follow-up. From a radiological perspective, only radial inclination (4°) and ulnar variance (mean difference 1.1 mm) at >3 months reached statistical significance in favor of the VLP group (both P < 0.05). Fewer complications were found in the VLP group (P < 0.05), but they did not result in different reintervention rates.ConclusionsThis meta-analysis showed that the surgical approach leads to a better clinical outcome in the first months, better fracture alignment, and lower complication rate. However, no differences in the clinical outcomes have been confirmed after 3 months. Overall, these findings suggest operative treatment for people with higher functional demand requiring a faster recovery, while they support the benefit of a more conservative approach in less demanding patients.

Project description:BackgroundDistal radius fractures (DRFs) in the elderly are common. Recently, the efficacy of operative treatment of displaced DRFs in patients above 65 years of age has been questioned and it has been suggested that non-operative treatment should be the gold standard. However, the complications and functional outcome of displaced vs. minimally and non-displaced DRFs in the elderly has not been evaluated yet. The aim of the present study was to compare non-operatively treated displaced DRFs vs. minimally and non-displaced DRFs in terms of complications, PROMs, grip strength and range of motion (ROM) after 2 weeks, 5 weeks, 6 months and 12 months.MethodsWe used a prospective cohort study that compared patients with displaced DRFs (n = 50), i.e., >10 degrees of dorsal angulation after two reduction attempts, with patients with minimally or non-displaced DRFs after reduction. Both cohorts received the same treatment of 5 weeks of dorsal plaster casting. Complications and functional outcomes (quick disabilities of the arm, shoulder and hand (QuickDASH), patient-rated wrist/hand evaluation (PRWHE), grip strength and EQ-5D scores) were assessed after 5 weeks, 6 months and 12 months post-injury. The protocol of the VOLCON RCT and present observational study has been published (PMC6599306; clinicaltrials.gov: NCT03716661).ResultsOne year after 5 weeks of dorsal below-elbow casting of low-energy DRFs in patients ≥ 65 years old, we found a complication rate of 6.3% (3/48) in minimally or non-displaced DRFs and 16.6% (7/42) in displaced DRFs (p = 0.18). However, no statistically significant difference was observed in functional outcomes in terms of QuickDASH, pain, ROM, grip strength or EQ-5D scores.DiscussionIn patients above 65 years of age, non-operative treatment, i.e., closed reduction and dorsal casting for 5 weeks, yielded similar complication rates and functional outcomes after 1 year regardless of whether the initial fracture was non-displaced/minimally displaced or still displaced after closed reduction. While the initial closed reduction should still be attempted in order to restore the anatomy, failure to achieve the stipulated radiological criteria may not be as important as we thought in terms of complications and functional outcome.

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Non-surgical vs. surgical treatment of distal radius fractures: a meta-analysis of randomized controlled trials

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