Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears

NCT05981833 | Recruiting FDA Device

• 1 other identifier: AIRR-0094
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 4

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).

Conditions

Full-thickness Rotator Cuff Tear

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is healing evaluation in MRI

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

  26 Weeks

Secondary Outcomes (4)

• The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems

  Preop, 26 Weeks, 1 Year, 2 Year

• Single Assessment Numeric Evaluation score (SANE)

  Preop, 26 Weeks, 1 Year, 2 Year

• Visual Analog Scale (VAS) for pain

  Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year

• Veterans RAND Health Survey (VR-12)

  Preop, 26 Weeks, 1 Year, 2 Year

Study Arms (1)

Repair without DAA

repaired without dermal allograft augmentation (DAA).

Device: Repair with DAA (dermal allograft augmentation)

Interventions

Repair with DAA (dermal allograft augmentation) DEVICE

Patients undergo rotator cuff repair with dermal allograft augmentation.

Repair without DAA

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.
• Partial rotator cuff repairs
• Lafosse grade 3 or higher subscapularis tears

Sponsors & Collaborators

• Arthrex, Inc.: lead

Study Sites (4)

University of Arizona, Banner Health

Scottsdale, Arizona, 85006, United States

RECRUITING

Orthopaedic & Nuerosurgery Specialists

Greenwich, Connecticut, 06831, United States

RECRUITING

Southern Oregon Orthopedics Research Foundation

Medford, Oregon, 97504, United States

RECRUITING

Tennessee Orthopedic Foundation for Research Education and Research

Nashville, Tennessee, 37204, United States

RECRUITING

Related Publications (11)

• Kwon J, Kim SH, Lee YH, Kim TI, Oh JH. The Rotator Cuff Healing Index: A New Scoring System to Predict Rotator Cuff Healing After Surgical Repair. Am J Sports Med. 2019 Jan;47(1):173-180. doi: 10.1177/0363546518810763. Epub 2018 Nov 28.

  PMID: 30485753 BACKGROUND

• Duong JKH, Lam PH, Murrell GAC. Anteroposterior tear size, age, hospital, and case number are important predictors of repair integrity: an analysis of 1962 consecutive arthroscopic single-row rotator cuff repairs. J Shoulder Elbow Surg. 2021 Aug;30(8):1907-1914. doi: 10.1016/j.jse.2020.09.038. Epub 2020 Nov 4.

  PMID: 33160028 BACKGROUND

• Pashuck TD, Hirahara AM, Cook JL, Cook CR, Andersen WJ, Smith MJ. Superior Capsular Reconstruction Using Dermal Allograft Is a Safe and Effective Treatment for Massive Irreparable Rotator Cuff Tears: 2-Year Clinical Outcomes. Arthroscopy. 2021 Feb;37(2):489-496.e1. doi: 10.1016/j.arthro.2020.10.014. Epub 2020 Oct 17.

  PMID: 33080333 BACKGROUND

• Jackson GR, Bedi A, Denard PJ. Graft Augmentation of Repairable Rotator Cuff Tears: An Algorithmic Approach Based on Healing Rates. Arthroscopy. 2022 Jul;38(7):2342-2347. doi: 10.1016/j.arthro.2021.10.032. Epub 2021 Nov 10.

  PMID: 34767956 BACKGROUND

• Omae H, Steinmann SP, Zhao C, Zobitz ME, Wongtriratanachai P, Sperling JW, An KN. Biomechanical effect of rotator cuff augmentation with an acellular dermal matrix graft: a cadaver study. Clin Biomech (Bristol). 2012 Oct;27(8):789-92. doi: 10.1016/j.clinbiomech.2012.05.001. Epub 2012 May 17.

  PMID: 22607908 BACKGROUND

• Snyder SJ, Arnoczky SP, Bond JL, Dopirak R. Histologic evaluation of a biopsy specimen obtained 3 months after rotator cuff augmentation with GraftJacket Matrix. Arthroscopy. 2009 Mar;25(3):329-33. doi: 10.1016/j.arthro.2008.05.023. Epub 2008 Jul 24.

  PMID: 19245998 BACKGROUND

• Barber FA, Burns JP, Deutsch A, Labbe MR, Litchfield RB. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair. Arthroscopy. 2012 Jan;28(1):8-15. doi: 10.1016/j.arthro.2011.06.038. Epub 2011 Oct 5.

  PMID: 21978432 BACKGROUND

• Cummins CA, Murrell GA. Mode of failure for rotator cuff repair with suture anchors identified at revision surgery. J Shoulder Elbow Surg. 2003 Mar-Apr;12(2):128-33. doi: 10.1067/mse.2003.21.

  PMID: 12700563 BACKGROUND

• Haque A, Pal Singh H. Does structural integrity following rotator cuff repair affect functional outcomes and pain scores? A meta-analysis. Shoulder Elbow. 2018 Jul;10(3):163-169. doi: 10.1177/1758573217731548. Epub 2017 Sep 25.

  PMID: 29796103 BACKGROUND

• Sugaya H, Maeda K, Matsuki K, Moriishi J. Repair integrity and functional outcome after arthroscopic double-row rotator cuff repair. A prospective outcome study. J Bone Joint Surg Am. 2007 May;89(5):953-60. doi: 10.2106/JBJS.F.00512.

  PMID: 17473131 BACKGROUND

• Mather J, MacDermid JC, Faber KJ, Athwal GS. Proximal humerus cortical bone thickness correlates with bone mineral density and can clinically rule out osteoporosis. J Shoulder Elbow Surg. 2013 Jun;22(6):732-8. doi: 10.1016/j.jse.2012.08.018. Epub 2012 Nov 22.

  PMID: 23183030 BACKGROUND

Study Officials

• Alicia Ruiz, MS

  Arthrex, Inc.

  STUDY DIRECTOR

Central Study Contacts

Caroline Caraci, BA

CONTACT

18009337001; caroline.caraci@arthrex.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 8, 2023
• Study Start: September 25, 2023
• Primary Completion: September 15, 2025
• Study Completion (Estimated): September 15, 2026
• Last Updated: February 24, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)