Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07027735
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Rotator Cuff Tear

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Rotator Cuff Repair with Allograft Patch — OTHER
    Rotator cuff repairs will be augmented with use of a decellularized human placental allograft patch
  • Rotator Cuff Repair with No Augmentation — OTHER
    Standard rotator cuff repair with no augmentation

Study Details

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.

Key Dates

First listed
Jun 18, 2025
Start date
Jan 31, 2027
Status verified
Sep 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment Arm
    Standard Rotator Cuff Repair + Receives Allograft Treatment
  • Other: Control Arm
    Standard Rotator Cuff Repair + NO Allograft Treatment

Primary Outcome Measure

Retear Rate [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
NewYorkPresbyterian Hospital @ Columbia University Irving Medical CenterNew YorkNew York10032-3702
William Levine, MD (PRINCIPAL_INVESTIGATOR)
Charles Jobin, MD (SUB_INVESTIGATOR)
Michael Knudsen, MD (SUB_INVESTIGATOR)

Find similar trials in New York, NY

By research site
NewYorkPresbyterian Hospital @ Columbia University Irving Medical Center· New York, NY

Related Studies