Operative versus Nonoperative Treatment of Proximal Hamstring AvulsionsShow others and affiliations
2024 (English)In: NEJM Evidence, E-ISSN 2766-5526, Vol. 3, no 8Article in journal (Refereed) Published
Abstract [en]
Background: Operative treatment is widely used for acute proximal hamstring avulsions, but its effectiveness compared with that of nonoperative treatment has not been shown in randomized trials.
Methods: In this noninferiority trial at 10 centers in Sweden and Norway, we enrolled patients 30 to 70 years of age with a proximal hamstring avulsion in a randomized trial and a parallel observational cohort. Treatments were operative reinsertion of the tendons or nonoperative management. The primary end point was the Perth Hamstring Assessment Tool (PHAT) at 2 years of follow-up. Secondary outcomes included scores on the Lower Extremity Functional Scale (LEFS).
Results: A total of 119 patients were enrolled in the randomized trial and 97 patients in the observational cohort. In the per-protocol analysis of the randomized trial, the mean (±standard deviation) PHAT scores were 79.9±19.5 and 78.5±19.4 in the operative and nonoperative groups, respectively (PHAT scores range from 0 to 100, with higher scores indicating higher function). The prespecified noninferiority limit of 10 points was not crossed (mean difference, −1.2; 95% confidence interval [CI], −8.6 to 6.2; P=0.009 for noninferiority). Analyses of secondary outcomes, including a mean difference in the LEFS score of −1.6 (95% CI, −5.2 to 2.0), aligned with the primary outcome. The observed numbers of adverse events in the randomized trial were nine in the operative group versus three in the nonoperative group (odds ratio, 0.3; 95% CI, 0.1 to 1.2). In the analysis of the observational cohort, the mean PHAT score difference between the nonoperative and operative treatment groups was −2.6 (95% CI, −9.9 to 4.6).
Conclusions: In patients 30 to 70 years of age with proximal hamstring avulsions, nonoperative treatment was noninferior to operative treatment. (Funded by Afa Försäkring and others; ClinicalTrials.gov number, NCT03311997.)
Place, publisher, year, edition, pages
Massachusetts Medical Society , 2024. Vol. 3, no 8
National Category
Orthopaedics
Identifiers
URN: urn:nbn:se:uu:diva-539058DOI: 10.1056/evidoa2400056ISI: 001534722600009OAI: oai:DiVA.org:uu-539058DiVA, id: diva2:1900554
2024-09-242024-09-242026-02-02Bibliographically approved
In thesis