Decellularized Human Placental Extracellular Matrix Tissue for Rotator Cuff Repair Augmentation

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

Start date

Aug 31, 2026

Status verified

Apr 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 ]

Central Contacts

• Andrew J Luzzi, MD
  18604595700
  [email protected]
• Dawn Vega
  [email protected]

Locations (1)

Find similar trials in New York, NY

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