Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue: a Prospective Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating the long-term safety and clinical effects of using autologous microfragmented lipoaspirate tissue during arthroscopic rotator cuff repair surgery. This study focuses on patients who had single-row arthroscopic rotator cuff repair and aims to assess whether adding this processed adipose tissue improves tendon healing and functional outcomes at least five years after surgery. The research builds on previous trials that showed short-term benefits and explores the potential of this biological approach to support tissue regeneration and reduce retear rates. Participants are grouped based on whether they received the arthroscopic rotator cuff repair with or without the injection of autologous microfragmented adipose tissue processed using an enzyme-free method. The adipose tissue is harvested and processed directly during surgery in a sterile environment, then immediately injected to potentially enhance healing. The study compares these two groups to evaluate differences in tendon integrity and shoulder function over time. At least five years after their surgery, all enrolled patients will undergo clinical evaluations including the Constant-Murley score, strength testing in shoulder movements, and questionnaires such as ASES, SST, and VAS to measure pain and shoulder function. They will also have an MRI scan to assess tendon healing and identify any retears. Researchers will compare clinical outcomes and imaging findings between groups, monitoring safety and effectiveness throughout the follow-up period to understand the long-term impact of this treatment approach.

Long Term Clinical Outcome After Arthroscopic Rotator Cuff Repair Augmentation With Autologous Microfragmented Lipoaspirate Tissue