Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation

NCT07027735 | Recruiting

• 1 other identifier: AAAV5510
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

rotator cuff tear

Outcome Measures

Primary Outcomes (1)

• Retear Rate

  The primary outcome measure will be the postoperative retear rate, measured on one-year postoperative MRI

  1 year

Secondary Outcomes (7)

• Tendon Structural Continuity (MRI)

  1 year

• Tendon Thickness (MRI)

  1 year

• Constant-Murley score

  1 year

• American Shoulder and Elbow Surgeons (ASES) score

  1 year

• Visual Analogue Scale (VAS) Pain scores

  1 year

Study Arms (2)

Treatment Arm

EXPERIMENTAL

Standard Rotator Cuff Repair + Receives Allograft Treatment

Other: Rotator Cuff Repair with Allograft Patch

Control Arm

OTHER

Standard Rotator Cuff Repair + NO Allograft Treatment

Other: Rotator Cuff Repair with No Augmentation

Interventions

Rotator Cuff Repair with Allograft Patch OTHER

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

Treatment Arm

Rotator Cuff Repair with No Augmentation OTHER

Standard rotator cuff repair with no augmentation

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Diagnosis of full thickness rotator cuff tear

You may not qualify if:

• Partial thickness tears
• Full thickness subscapularis tears
• Goutallier grades 3 and 4
• Prior rotator cuff surgery

Sponsors & Collaborators

• Columbia University: lead
• CTM Biomedical: collaborator

Study Sites (1)

NewYorkPresbyterian Hospital @ Columbia

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

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Officials

• William Levine, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew J Luzzi, MD

CONTACT

18604595700; al3896@cumc.columbia.edu

Dawn Vega

CONTACT

dv2356@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 18, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)