Actively Recruiting
Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation
Led by Columbia University · Updated on 2026-04-16
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
C
CTM Biomedical
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 18 years
- Diagnosis of full thickness rotator cuff tear
You will not qualify if you...
- Partial thickness tears
- Full thickness subscapularis tears
- Goutallier grades 3 and 4 fatty degeneration
- Prior rotator cuff surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo rotator cuff repair surgery either with a decellularized human placental allograft patch or standard repair without augmentation.
1 surgery visit (in-person)
Duration - 12 months
Participants attend follow-up visits for physical assessments and rehabilitation monitoring after surgery.
Visits at 2 weeks, 3 months, 6 months, and 12 months (all in-person)
Duration - 1 day at 12 months post-surgery
An MRI is performed to assess tendon repair integrity and structural outcomes.
1 MRI visit (in-person)
Trial Site Locations
Total: 1 location
1
NewYorkPresbyterian Hospital @ Columbia
New York, New York, United States, 10032-3702
Actively Recruiting
Research Team
A
Andrew J Luzzi, MD
D
Dawn Vega
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here