Dataset Information

No benefit for elbow blocking on conservative treatment of distal radius fractures: A 6-month randomized controlled trial.

ABSTRACT:

Purpose

For displaced distal radius fracture, this trial aimed to compare an above-elbow (AE) and below-elbow (BE) cast at the end of a 24-week follow-up using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire as a primary outcome.

Methods

This is a clinical trial with parallel groups (1:1) and a blinded evaluator. There are two non-surgical interventions: AE and BE. A total of 128 adult patients with acute (up to 7 days) displaced distal radius fracture of type A2-3, C1-3 by the AO classification were included. The follow-up was 24 weeks. The primary outcome was the DASH questionnaire at 24 weeks. Secondary outcomes were the maintenance of reduction by the evaluation of radiographic parameters, pain measured by VAS, PRWE, objective functional evaluation and rate of adverse effects.

Results

The difference between the two groups in the DASH score at 24 weeks was not significant, with the mean (95% CI) DASH score being AE: 9.44 (2.70 to 16.17) vs. BE: 9.88 (3.19 to 16.57) (p = 0.895). The above-elbow group had a significantly greater worsening of the mean DASH score from baseline to 2 weeks (p < 0.001). No statistically significant differences were found between the 2 groups in any of the other follow-up assessments. Objective functional evaluation, PRWE, radiographical measures and rates of reduction loss were similar between groups. Above-elbow casting resulted in more adverse effects (mostly shoulder pain; 19 events vs. 9 events); RR = 0.39 (0.19-0.94); p = 0.033 at the end of six-month follow-up.

Conclusions

This study did not demonstrate a difference between above-elbow and below-elbow cast in terms of DASH outcome at 6 months in non-surgical treatment of deviated distal radius fractures. However, below-elbow casting is less debilitating during the treatment period, has comparable performance in maintaining the reduction, and is related to fewer minor adverse effects than above-elbow casting.

SUBMITTER: Okamura A

PROVIDER: S-EPMC8191961 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Distal radial fractures are common traumatic injuries, but their management remains controversial also in case of conservative treatment regarding the type of immobilisation. Hence, we conducted a two-arm, parallel-group, prospective randomised trial to compare the capacity of long casts (above-elbow) and short casts (below-elbow) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (AO/OTA classification: 2R3A2.2). METHODS:Seventy-four eligible patients with AO/OTA 2R3A2.2 fractures treated with closed reduction and cast immobilisation were randomised to the long cast group (n°= 37) or to the short cast group (n°= 37). Baseline radiological parameters, radial inclination (RI), radial height (RH), ulnar variance (UV) and palmar tilt (PT) were taken, and compared with clinical (DASH, Mayo Wrist and Mayo Elbow) and radiological scores taken at 7-10 days, 4 weeks and 12 weeks. Furthermore, to evaluate correlations between radiological parameters and functional outcomes, patients were divided into two groups according to whether or not their radiological parameters at Follow-ups 2 and 3 were acceptable, i.e. within the range 11-12 mm for RH, 16°-28° for RI, - 4-+ 2 mm for UV and 0°-22° for PT. RESULTS:Patient demographic and baseline radiological parameters were similar between groups. At follow-up, there were no statistically significant differences between the two types of cast in terms of RI, RH, UV or PT, or Mayo wrist or DASH scores. Short cast group patients displayed better Mayo elbow score at follow-up 2 (4 weeks), but this difference was no longer statistically significant at follow-up 3 (12 weeks). No statistically significant differences in clinical outcomes were found between patients who presented acceptable radiographic parameters at follow-up and those who did not. CONCLUSION:As there were no significant differences between short casts and long casts in terms of fracture reduction maintenance or clinical outcomes, short casts are an effective method of post-reduction immobilisation in AO/OTA 2R3A2.2 fracture of the radius. Radiological parameters outside the range conventionally considered acceptable do not preclude a satisfactory clinical outcome. TRIAL REGISTRATION:ClinicalTrials.gov PRS, NCT04062110. Registred 20 August 2019.

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.