Application of biomimetic double-layer biofilm stent in arthroscopic rotator cuff repair A protocol of randomized controlled trial

Background: Rotator cuff injury is the most common cause of shoulder dysfunction. Despite the continuous advancement of surgical techniques, the incidence of re-tearing after rotator cuff repair is still high. The main reason is that it is difficult to reconstruct the normal tendon bone interface and the process is slow, and the application of tissue engineering technology can promote tendon and bone healing. This study will evaluate the effect of the bionic double membrane stent on the rotator cuff healing after arthroscopic rotator cuff repair. Methods: This is a prospective randomized controlled trial to study the effect of biomimetic double-layer biofilm stent on rotator cuff healing. Approved by the clinical research ethics committee of our hospital. The patients were randomly divided into 1 of 2 treatment options: (A) a biomimetic double-layer biofilm stent group and (B) a non-bionic dual-layer biofilm stent group. Observation indicators include: visual analog scale score, University of California Los Angeles score, American Shoulder & Elbow Surgeons score and Constant-Murley score. Data were analyzed using the statistical software package SPSS version 16.0 (Chicago, IL). Discussion: This study will evaluate and evaluate the effect of the bionic double-layer membrane stent on the rotator cuff healing after arthroscopic rotator cuff repair. The results of this experiment will provide new treatment ideas for promoting rotator cuff tendon bone healing. OSF Registration number: DOI 10.17605/OSF.IO/FWKD6