Clinical trial NCT05981833: Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
Official title: A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Full-thickness Rotator Cuff Tear
Lead sponsor: Arthrex, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-08
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome measure is healing evaluation in MRI
timeFrame: 26 Weeks
Secondary outcomes:
measure: The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems
timeFrame: Preop, 26 Weeks, 1 Year, 2 Year
measure: Single Assessment Numeric Evaluation score (SANE)
timeFrame: Preop, 26 Weeks, 1 Year, 2 Year
measure: Visual Analog Scale (VAS) for pain
timeFrame: Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year
measure: Veterans RAND Health Survey (VR-12)
timeFrame: Preop, 26 Weeks, 1 Year, 2 Year
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: University of Arizona, Banner Health
state: Arizona
city: Greenwich
country: United States
facility: Orthopaedic & Nuerosurgery Specialists
state: Connecticut
city: Medford
country: United States
facility: Southern Oregon Orthopedics Research Foundation
state: Oregon
city: Nashville
country: United States
facility: Tennessee Orthopedic Foundation for Research Education and Research
state: Tennessee
Study officials:
affiliation: Arthrex, Inc.
name: Alicia Ruiz, MS
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.