Recruiting

Allograft Treatment

Sponsor:

Columbia University

Code:

NCT07027735

Conditions

Rotator Cuff Tear

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Rotator Cuff Repair with Allograft Patch

Rotator Cuff Repair with No Augmentation

Study Details

Brief 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.

Conditions

Rotator Cuff Tear

Study ID

NCT07027735

Start date

Aug, 2026

Status verified date

Apr, 2026

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Arm

Standard Rotator Cuff Repair + Receives Allograft Treatment

other: Control Arm

Standard Rotator Cuff Repair + NO Allograft Treatment

Interventions

Rotator Cuff Repair with Allograft Patch

Rotator cuff repairs will be augmented with use of a decellularized human placental allograft patch

Rotator Cuff Repair with No Augmentation

Standard rotator cuff repair with no augmentation

Primary outcome measure

  • Retear Rate [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

NewYorkPresbyterian Hospital @ Columbia

Recruiting

New York, New York, United States, 10032-3702

Contacts

Principal Investigator:

William Levine, MD

More Information

Sponsor

Columbia University

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • rotator cuff tear

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2026-04-16.