Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

March 4, 2024 updated by: Arthrex, Inc.

A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

The purpose of this study is to compare postoperative healing of large and massive rotator cuff tears with preoperative MRI confirmed fatty infiltration stage II and higher repaired with or without dermal allograft augmentation (DAA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The primary objective is to evaluate postoperative healing of rotator cuff repair with and without DAA.

Primary: The primary outcome measure is healing evaluation in MRI . MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)

Secondary: The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems, including:

American Shoulder and Elbow Surgeons Score (ASES)

Single Assessment Numeric Evaluation score (SANE)

Visual Analog Scale (VAS) for pain

Veterans RAND Health Survey (VR-12)

Population: Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears

Description of Treatment: Rotator cuff repair with or without augmentation using decellularized human dermal allograft.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
      • Greenwich, Connecticut, United States, 06831
        • Recruiting
        • Orthopaedic & Nuerosurgery Specialists
        • Contact:
          • Paul Sethi, MD
          • Phone Number: 203-869-1145
        • Principal Investigator:
          • Paul Sethi, MD
    • Oregon
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Southern Oregon Orthopedics Research Foundation
        • Contact:
          • Patrick Denard
          • Phone Number: 541-608-2595
        • Principal Investigator:
          • Patrick Denard, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37204
        • Recruiting
        • Tennessee Orthopedic Foundation for Research Education and Research
        • Principal Investigator:
          • Paul Brady, MD
        • Contact:
          • Paul Brady

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears

Description

Inclusion Criteria:

  • The subject is between the ages of 30 and 75 years.
  • Subject is planning to undergo arthroscopic surgery for full-thickness rotator cuff tear (RCT)
  • Two complete RCTs or tear size equal to or greater than 3 cm in either the anterior-posterior or medial-lateral dimension
  • Primary rotator cuff repair
  • Stage II fatty infiltration or higher of the supraspinatus or infraspinatus muscle based on preoperative MRI6. Subject has a dual x-ray absorptiometry (DXA) or anterior posterior x-ray view of the target shoulder

Exclusion Criteria:

  • The Subject is unable or unwilling to sign the patient informed consent, approved by the Institutional Review Board.
  • The subject objects to the use of allograft
  • Stage I or lower fatty infiltration of the supraspinatus AND infraspinatus muscle
  • Complete full-thickness subscapularis tears of greater than the superior one third of the tendon (Lafosse grade 3 and above)
  • Less than 2 mm joint space of the glenohumeral joint on either an anteroposterior or axillary radiograph
  • Recurrent shoulder instability
  • Corticosteroid injection in the operative shoulder within one month of surgery
  • Revision rotator cuff repair
  • Subject preoperative MRI obtained more than 12 months prior to surgery
  • Pregnant or planning to become pregnant during the study period
  • Workman's compensation case
  • Subject has conditions or circumstances that would interfere with study requirements.

Intraoperative exclusion criteria:

Partial rotator cuff repairs

Lafosse grade 3 or higher subscapularis tears

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Repair without DAA
repaired without dermal allograft augmentation (DAA).
Device: Repair with DAA (dermal allograft augmentation)
Patients undergo rotator cuff repair with dermal allograft augmentation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome measure is healing evaluation in MRI
Time Frame: 26 Weeks

MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)

MRI Post-Operative Assessment (Goutallier Stage and Sugaya Classification)
26 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems
Time Frame: Preop, 26 Weeks, 1 Year, 2 Year
1. American Shoulder and Elbow Surgeons Score (ASES) A combination of objective measures and patient-reported outcomes, it measures pain and functional limitations in the shoulder. The objective questionnaire allows documentation of range of motion in the patient.
Preop, 26 Weeks, 1 Year, 2 Year
Single Assessment Numeric Evaluation score (SANE)
Time Frame: Preop, 26 Weeks, 1 Year, 2 Year
Asks patients to rate shoulder pain as a percentage of normal.
Preop, 26 Weeks, 1 Year, 2 Year
Visual Analog Scale (VAS) for pain
Time Frame: Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year
The standard measure for pain on a 0-10 scale, 10 being the worst.
Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year
Veterans RAND Health Survey (VR-12)
Time Frame: Preop, 26 Weeks, 1 Year, 2 Year
A self-administered health measure. Answers are summarized into two scores, a Physical Component Score and a Mental Component Score, which provides an important contrast between the respondents' physical and psychological health status.
Preop, 26 Weeks, 1 Year, 2 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthrex, Inc.

Investigators

  • Study Director: Alicia Ruiz, MS, Arthrex, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

September 15, 2025

Study Completion (Estimated)

September 15, 2026

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIRR-0094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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