Using Decellularized Human Placental Tissue to Help Heal Full Thickness Rotator Cuff Tears After Surgery

What this Trial Is About

Rotator cuff tears are common injuries that affect the muscles and tendons around the shoulder and often require surgical repair. This research aims to evaluate the use of a decellularized human placental extracellular matrix allograft patch to improve healing after rotator cuff repair. The study is a prospective randomized controlled trial comparing standard rotator cuff repair surgery with and without this allograft treatment to better understand postoperative healing outcomes. Participants are randomly assigned to one of two groups one receiving the standard rotator cuff repair augmented with the allograft patch, and the other receiving standard repair without augmentation. The allograft is a tissue scaffold derived from human placentas that supports tissue remodeling. Both groups will follow similar rehabilitation programs. The study includes preoperative screening and postoperative follow-up visits at 2 weeks, 3 months, 6 months, and 12 months after surgery. During the study, participants will undergo an MRI at one year post-surgery to assess tendon healing, which is not typically standard care. Researchers will measure the retear rate as the primary outcome, along with additional MRI assessments like tendon thickness and structural continuity. Patient-reported outcomes on pain and shoulder function will also be collected at each visit. The study will monitor healing progress and any incidental MRI findings according to standard medical practice, with total participation lasting about one year postoperatively.

Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation