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Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

Sponsor
Arthrex, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05981833
Collaborator
(none)
120
Enrollment
36
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Repair with DAA (dermal allograft augmentation)

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 Design

Study Type:
Observational
Anticipated Enrollment :
120 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2025
Anticipated Study Completion Date :
Sep 1, 2026

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The primary outcome measure is healing evaluation in MRI [26 Weeks]

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

Secondary Outcome Measures

  1. The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems [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.

  2. Single Assessment Numeric Evaluation score (SANE) [Preop, 26 Weeks, 1 Year, 2 Year]

    Asks patients to rate shoulder pain as a percentage of normal.

  3. Visual Analog Scale (VAS) for pain [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.

  4. Veterans RAND Health Survey (VR-12) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Arthrex, Inc.

Investigators

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

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Arthrex, Inc.
ClinicalTrials.gov Identifier:
NCT05981833
Other Study ID Numbers:
  • AIRR-0094
First Posted:
Aug 8, 2023
Last Update Posted:
Aug 8, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Rotator Cuff Injuries

Study Results

No Results Posted as of Aug 8, 2023