Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation
Columbia University
Summary
The rotator cuff is a set of muscles and tendons that help move the shoulder. Tears in the rotator cuff are common, particularly as people age. Consequently, rotator cuff repair surgeries are common, as well. Despite the frequency with which rotator cuff repairs are performed, there remains a high rate of postoperative failure to heal. In such situations, there is a lack of connective tissue establishment between the rotator cuff tendon and the bone. One strategy to attempt to improve healing of the rotator cuff tendon back to the bone is via the use of extracellular matrix allograft. This treatment is composed of tissue from other humans, which is stripped of its cells so that just the scaffolding around the cells remains. This decellularized scaffolding can be placed at the rotator cuff healing site in an attempt to augment healing. Both animal studies and human studies have shown promise with this approach. Of those patients enrolling in the study, 50% will be assigned at random to receive a standard rotator cuff repair AND allograft treatment, while 50% will be assigned at random to receive standard rotator cuff repair WITHOUT allograft treatment. All patients enrolled in the study will also obtain an MRI at one year following surgery in order to assess tendon healing. Of note, one-year postoperative MRIs are not standard following rotator cuff repair - only those enrolled in the study will receive this MRI. There will be no financial consequence of receiving this MRI.
Description
Rotator cuff repair is one of the most commonly performed orthopedic surgeries, with over 450,000 surgeries performed every year in the United States. Unfortunately, the failure rate postoperatively remains unacceptably high despite advances in surgical techniques and rehabilitation strategies. Clinical studies have shown that only about half of repaired rotator cuffs heal by 12 months following surgery, with the rate of recurrent tears ranging from 20% in the best case and as high as 94% in certain patient populations with massive tears. Animal model studies indicate that the high failure rat…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Age ≥ 18 years * Diagnosis of full thickness rotator cuff tear Exclusion Criteria: * Partial thickness tears * Full thickness subscapularis tears * Goutallier grades 3 and 4 * Prior rotator cuff surgery
Interventions
- OtherRotator Cuff Repair with Allograft Patch
Rotator cuff repairs will be augmented with use of a decellularized human placental allograft patch
- OtherRotator Cuff Repair with No Augmentation
Standard rotator cuff repair with no augmentation
Location
- NewYorkPresbyterian Hospital @ ColumbiaNew York, New York