Full-thickness Rotator Cuff TearNCT05981833
Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
An observational study of Full-thickness Rotator Cuff Tear, run by Arthrex, Inc. at 4 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Full-thickness Rotator Cuff Tear
- What is being tested?
- Repair with DAA (dermal allograft augmentation)
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2023to 15 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 4 recruiting
- Recruiting
Orthopaedic & Nuerosurgery Specialists
Greenwich, Connecticut, 06831
Paul Sethi, MD, 2038691145
Paul Sethi, MD
- Recruiting
Southern Oregon Orthopedics Research Foundation
Medford, Oregon, 97504
Patrick Denard, 5416082595
Patrick Denard, MD
- Recruiting
Tennessee Orthopedic Foundation for Research Education and Research
Nashville, Tennessee, 37204
Paul Brady
Paul Brady, MD
- Recruiting
University of Arizona, Banner Health
Scottsdale, Arizona, 85006
Anup Shah, MD
Anup Shah, MD
About this study
Official title: 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).
Read the 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.
- Conditions
- Full-thickness Rotator Cuff Tear
- Being tested
- Repair with DAA (dermal allograft augmentation)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repair with DAA (dermal allograft augmentation)Device
Patients undergo rotator cuff repair with dermal allograft augmentation.
| Study group | Role | What they receive |
|---|---|---|
| Repair without DAA | repaired without dermal allograft augmentation (DAA). Receives: Device: Repair with DAA (dermal allograft augmentation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 26 Weeks
Secondary outcomes (4)
The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems
- 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.
Measured: Preop, 26 Weeks, 1 Year, 2 Year
Single Assessment Numeric Evaluation score (SANE)
Asks patients to rate shoulder pain as a percentage of normal.
Measured: Preop, 26 Weeks, 1 Year, 2 Year
Visual Analog Scale (VAS) for pain
The standard measure for pain on a 0-10 scale, 10 being the worst.
Measured: Preop, two-week, six week, 26 Weeks, 1 Year, 2 Year
Veterans RAND Health Survey (VR-12)
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.
Measured: Preop, 26 Weeks, 1 Year, 2 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start25 Sep 2023
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Full-thickness Rotator Cuff TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthrex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia Ruiz, MS, Study director, Arthrex, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981833
- Sponsor's protocol ID
- AIRR-0094
- Status last verified
- Mar 2024
- First submitted
- 1 Aug 2023
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30485753Duong 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.
PubMed 33160028Pashuck 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.
PubMed 33080333Jackson 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.
PubMed 34767956Omae 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.
PubMed 22607908Snyder 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.
PubMed 19245998Barber 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.
PubMed 21978432Cummins 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.
PubMed 12700563Haque 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.
PubMed 29796103Sugaya 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.
PubMed 17473131Mather 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.
PubMed 23183030
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Post-market Study Evaluating Dermal Allograft Augmentation of Large and Massive Rotator Cuff Tears
- ClinicalTrials.gov ID
- NCT05981833
- Acronym / sponsor ID
- AIRR-0094
- Conditions
- Full-thickness Rotator Cuff Tear
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Arthrex, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2023 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 8 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repair without DAA | – | Device: Repair with DAA (dermal allograft augmentation)repaired without dermal allograft augmentation (DAA). |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females between the ages of 30 and 75 years that require surgery for large and massive rotator cuff tears
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repair with DAA (dermal allograft augmentation)Patients undergo rotator cuff repair with dermal allograft augmentation. | Device | Repair without DAA |
Primary outcome
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)
4 secondary outcomes
The secondary outcome measures are patient-reported outcome measures from validated outcome scoring systems
Time frame: Preop, 26 Weeks, 1 Year, 2 Year
Single Assessment Numeric Evaluation score (SANE)
Time frame: 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
Veterans RAND Health Survey (VR-12)
Time frame: Preop, 26 Weeks, 1 Year, 2 Year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Background: PubMed 30485753Kwon 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.
- Background: PubMed 33160028Duong 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.
- Background: PubMed 33080333Pashuck 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.
- Background: PubMed 34767956Jackson 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.
- Background: PubMed 22607908Omae 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.
- Background: PubMed 19245998Snyder 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.
- Background: PubMed 21978432Barber 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.
- Background: PubMed 12700563Cummins 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.
- Background: PubMed 29796103Haque 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.
- Background: PubMed 17473131Sugaya 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.
- Background: PubMed 23183030Mather 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia Ruiz, MS study director
Arthrex, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Full-thickness Rotator Cuff Tear, run by Arthrex, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline Caraci, BA (18009337001, caroline.caraci@arthrex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is healing evaluation in MRI (time frame: 26 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05981833, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.