10.1177/1056789514562152

Vollständiger Abstract

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BACKGROUND: Supervised hand therapy (SHT) with early mobilization is recommended for patients with a stable, congruent proximal interphalangeal (PIP) joint after dorsal dislocation or hyperextension injury with a volar plate avulsion. Early mobilization uses a dorsal block splint. A self-management exercise regimen (SMER) may offer a valuable alternative that reduces demand on therapists. We hypothesized that SMER is noninferior to SHT. METHODS: Noninferiority was assessed in adult patients in a multicenter, open randomized trial. Noninferiority to SHT had to be shown in both the modified intention-to-treat (mITT) and per-protocol (PP) analysis sets. The predefined noninferiority margin was -8 points, about half the minimal clinically important difference, with a 1-sided critical P value of .025. RESULTS: The mITT analysis set contained 100 patients in each treatment group. The mean difference at 3 months in Michigan Hand Outcomes Questionnaire (MHQ) change score from baseline was -0.6 (95% CI, -4.4 to 3.2; Pnoninferiority = .0001) against SMER. The PP analysis set consisted of 85 patients who followed SMER and 79 patients who received SHT. The mean difference at 3 months in MHQ change score from baseline was 0.4 (95% CI, -3.5 to 4.4; Pnoninferiority = .000026) in favor of SMER. No safety issues following SMER were observed. CONCLUSIONS: The randomized controlled trial showed that SMER for patients with a stable and congruent joint alignment after dorsal dislocation or hyperextension injury with a volar plate avulsion fracture of the PIP joint is clinically noninferior regarding hand function compared with SHT. LEVEL OF EVIDENCE: I.

Abstract: PubMed · Datensatz