Use of a bioresorbable polylactide sheet (OrthoWrap Bioresorbable sheet) on tendon healing after extensor tendon repair: a controlled clinical trial.

BACKGROUND

Adhesion formation poses a significant challenge for both patients and hand surgeons following tendon repair. One common strategy to prevent adhesion formation is the use of physical barriers. This study aimed to compare the outcomes of extensor tendon repair with and without the application of the OrthoWrap bioresorbable Sheet, specifically in terms of adhesion prevention.

METHODS

This triple-blind randomized clinical trial was conducted on patients with trauma to the extensor zone VI tendons. Participants were randomly assigned to one of two groups. In the intervention group, OrthoWrap bioresorbable Sheet was applied in addition to the standard tendon repair protocol. Over a three-month follow-up period, the Visual Analogue Scale (VAS) score, extension lag, and metacarpophalangeal joint flexion were assessed. Additionally, the mobility of the proximal interphalangeal (PIP) and distal interphalangeal (DIP) joints was evaluated using the Strickland classification.

RESULTS

A total of 42 patients in the OrthoWrap group and 43 in the control group were evaluated over the three-month period. Both groups showed a significant reduction in mean extension lag at the metacarpophalangeal joint over time. No significant condition-by-time interactions were found for MP joint flexion or VAS scores (p > 0.05). However, significant improvements in MP joint flexion and VAS scores were observed over time. The OrthoWrap group demonstrated significantly more favorable outcomes compared to the control group.

CONCLUSION

The clinical application of OrthoWrap in extensor tendon repair demonstrated statistically significant but modest improvements in extension lag (2.5°). While patients treated with OrthoWrap showed better outcomes in Strickland's classification, the clinical significance of these small differences and their impact on patient function requires further investigation.

TRIAL REGISTRATION

IRCT, IRCT20180627040252N3. Registered 20,220,617, Https//irct.behdasht.gov.ir/trial/56,652.