Rotator Cuff TearsNCT07890831
Dermis on Demand Allograft Augmentation for Rotator Cuff Repair
A study testing Arthroscopic rotator cuff repair; Biological: Dermis on Demand and Arthroscopic rotator cuff repair in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by University of Cincinnati at 1 site in United States.
Trial summary
The purpose of this study is to find out whether adding a human acellular dermal allograft (Dermis on Demand) during arthroscopic rotator cuff repair improves tendon-to-bone healing and lowers the rate of re-tear compared to standard repair alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries
- What is being tested?
- Arthroscopic rotator cuff repair; Biological: Dermis on Demand and Arthroscopic rotator cuff repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Dec 2021to 15 May 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Reparable, large (3-5 cm), full-thickness superior or posterosuperior rotator cuff tear confirmed by MRI
- Scheduled for arthroscopic rotator cuff repair with the study surgeon
- Able to provide written informed consent
Who cannot join
- Previous failed rotator cuff repair
- Subscapularis pathology
- Goutallier grade III or IV fatty atrophy
- Teres minor tear
- Tendon retraction greater than 22.2 mm [CONFIRM; see issue #4]
- Inflammatory or autoimmune disease
- Signs or symptoms of rotator cuff tear arthropathy
- Intraoperative: tear not amenable to transosseous-equivalent knotless repair, or incomplete graft coverage
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati / UC Health Orthopaedics & Sports Medicine
Cincinnati, Ohio, 45267
About this study
Official title: A Randomized Control Trial Assessing the Efficacy of the Dermis on Demand for Rotator Cuff Repair
The purpose of this study is to find out whether adding a human acellular dermal allograft (Dermis on Demand) during arthroscopic rotator cuff repair improves tendon-to-bone healing and lowers the rate of re-tear compared to standard repair alone. Sixty adults with large (3-5 cm) full-thickness superior or posterosuperior rotator cuff tears will be randomly assigned to repair with or without the allograft. Healing will be assessed by MRI at 12 months and by ultrasound at 6 months after surgery. Patient-reported outcomes, shoulder range of motion and strength, and operative time will also be compared between the groups.
Read the detailed description
Rotator cuff repair has a high failure rate (approximately 40%), most often at the tendon-suture interface. Traditional acellular dermal allograft augmentation has shown improved healing, but it adds 1-2 hours to operative time, uses a fixed graft thickness, and requires slower rehabilitation. Dermis on Demand (CellRight Technologies) is a cannulated, shelf-stable acellular dermal allograft that can be loaded onto suture tapes and incorporated arthroscopically into the repair construct in about 30 seconds per piece. Multiple pieces can be combined to build a custom-sized patch.
In this single-surgeon randomized controlled trial, 60 patients will be assigned using block randomization (15 blocks of 4) to either knotless double-row transosseous-equivalent repair augmented with 2-3 Dermis on Demand pieces (Allograft group) or the identical repair construct without augmentation (Control group). All patients follow the same postoperative rehabilitation protocol: abduction sling for 4 weeks, supervised rehabilitation starting at 2 weeks, and formal strengthening at 12 weeks.
The primary outcome is re-tear rate on research MRI at 12 months. A fellowship-trained musculoskeletal radiologist will grade the MRIs twice, with a 6-week washout between readings, using the Sugaya classification, the Crim rotator cuff score, and the Goutallier classification. Secondary outcomes include 6-month ultrasound assessment of repair integrity, patient-reported outcomes (ASES, SANE, PROMIS Upper Extremity, SF-12), range of motion, strength, and operative time. The study hypothesizes that allograft augmentation will improve structural healing and clinical outcomes without increasing operative time.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Being tested
- Arthroscopic rotator cuff repair; Biological: Dermis on Demand, Arthroscopic rotator cuff repair
- Keywords
- rotator cuff repair, acellular dermal allograft, graft augmentation, Dermis on Demand, tendon-to-bone healing, retear, arthroscopic shoulder surgery
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic rotator cuff repair; Biological: Dermis on DemandProcedure or surgery
Arthroscopic knotless double-row transosseous-equivalent rotator cuff repair augmented with 2-3 Dermis on Demand acellular dermal allograft pieces loaded onto lateral-row suture tapes
Arthroscopic rotator cuff repairProcedure or surgery
A human acellular dermal allograft (CellRight Technologies) with a cannulated design, loaded onto suture tape and compressed onto the repaired footprint during lateral-row anchor seating. Other names: DOD; acellular dermal allograft.
| Study group | Role | What they receive |
|---|---|---|
| Allograft Augmentation | Experimental | Arthroscopic knotless double-row transosseous-equivalent rotator cuff repair augmented with 2-3 Dermis on Demand acellular dermal allograft pieces loaded onto lateral-row suture tapes Receives: Procedure: Arthroscopic rotator cuff repair; Biological: Dermis on Demand |
| Standard Repair | Active comparator | Identical arthroscopic knotless double-row transosseous-equivalent repair construct without allograft Receives: Procedure: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rotator cuff retear rate
Proportion of participants with a retear on MRI, defined as Sugaya type IV or V (scale I-V; higher = worse integrity)
Measured: 12 months postoperatively
Secondary outcomes (10)
MRI rotator cuff score
Sum of footprint size, tendon thickness, and signal intensity, each graded 1-4 (Crim et al., 2010). Total range 3-12; 12 = normal tendon.
Measured: 12 months
Fatty infiltration
Goutallier grade 0-4 (higher = more fatty infiltration)
Measured: 12 months
Ultrasound repair integrity
Proportion with intact repair on shoulder ultrasound
Measured: 6 months
ASES score
American Shoulder and Elbow Surgeons score, 0-100 (higher = better)
Measured: Baseline, 6 wk, 3, 6, 12 months
SANE score
Single Assessment Numeric Evaluation, 0-100% (higher = better)
Measured: Baseline, 6 wk, 3, 6, 12 months
PROMIS Upper Extremity
T-score, population mean 50, SD 10 (higher = better function)
Measured: Baseline, 6 wk, 3, 6, 12 months
SF-12
Physical and Mental Component Summary scores, norm-based, mean 50 (higher = better)
Measured: Baseline, 6 wk, 3, 6, 12 months
Shoulder range of motion
Forward flexion, abduction, external and internal rotation, in degrees
Measured: Baseline, 6 wk, 3, 6, 12 months
Shoulder strength
Manual muscle testing, graded 0-5
Measured: Baseline, 6 wk, 3, 6, 12 months
Operative time
Minutes from incision to closure
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start2 Dec 2021
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Grawe, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07890831
- Sponsor's protocol ID
- SM21037
- Other IDs
- IRB #2021-0487
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goutallier D, Postel JM, Radier C, Bernageau J, Zilber S. Long-term functional and structural outcome in patients with intact repairs 1 year after open transosseous rotator cuff repair. J Shoulder Elbow Surg. 2009 Jul-Aug;18(4):521-8. doi: 10.1016/j.jse.2008.11.006. Epub 2009 Feb 11.
PubMed 19213574Sugaya 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 17473131Crim J, Burks R, Manaster BJ, Hanrahan C, Hung M, Greis P. Temporal evolution of MRI findings after arthroscopic rotator cuff repair. AJR Am J Roentgenol. 2010 Dec;195(6):1361-6. doi: 10.2214/AJR.10.4436.
PubMed 21098196
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Assessing the Efficacy of the Dermis on Demand for Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07890831
- Acronym / sponsor ID
- SM21037
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Keywords
- rotator cuff repair, acellular dermal allograft, graft augmentation, Dermis on Demand, tendon-to-bone healing, retear, arthroscopic shoulder surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Study start
- 2 Dec 2021 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 22 Oct 2026 (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 find out whether adding a human acellular dermal allograft (Dermis on Demand) during arthroscopic rotator cuff repair improves tendon-to-bone healing and lowers the rate of re-tear compared to standard repair alone. Sixty adults with large (3-5 cm) full-thickness superior or posterosuperior rotator cuff tears will be randomly assigned to repair with or without the allograft. Healing will be assessed by MRI at 12 months and by ultrasound at 6 months after surgery. Patient-reported outcomes, shoulder range of motion and strength, and operative time will also be compared between the groups.
Detailed description
Rotator cuff repair has a high failure rate (approximately 40%), most often at the tendon-suture interface. Traditional acellular dermal allograft augmentation has shown improved healing, but it adds 1-2 hours to operative time, uses a fixed graft thickness, and requires slower rehabilitation. Dermis on Demand (CellRight Technologies) is a cannulated, shelf-stable acellular dermal allograft that can be loaded onto suture tapes and incorporated arthroscopically into the repair construct in about 30 seconds per piece. Multiple pieces can be combined to build a custom-sized patch.
In this single-surgeon randomized controlled trial, 60 patients will be assigned using block randomization (15 blocks of 4) to either knotless double-row transosseous-equivalent repair augmented with 2-3 Dermis on Demand pieces (Allograft group) or the identical repair construct without augmentation (Control group). All patients follow the same postoperative rehabilitation protocol: abduction sling for 4 weeks, supervised rehabilitation starting at 2 weeks, and formal strengthening at 12 weeks.
The primary outcome is re-tear rate on research MRI at 12 months. A fellowship-trained musculoskeletal radiologist will grade the MRIs twice, with a 6-week washout between readings, using the Sugaya classification, the Crim rotator cuff score, and the Goutallier classification. Secondary outcomes include 6-month ultrasound assessment of repair integrity, patient-reported outcomes (ASES, SANE, PROMIS Upper Extremity, SF-12), range of motion, strength, and operative time. The study hypothesizes that allograft augmentation will improve structural healing and clinical outcomes without increasing operative time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Allograft Augmentation | Experimental | Procedure: Arthroscopic rotator cuff repair; Biological: Dermis on DemandArthroscopic knotless double-row transosseous-equivalent rotator cuff repair augmented with 2-3 Dermis on Demand acellular dermal allograft pieces loaded onto lateral-row suture tapes |
| Standard Repair | Active comparator | Procedure: Arthroscopic rotator cuff repairIdentical arthroscopic knotless double-row transosseous-equivalent repair construct without allograft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 or older
- Reparable, large (3-5 cm), full-thickness superior or posterosuperior rotator cuff tear confirmed by MRI
- Scheduled for arthroscopic rotator cuff repair with the study surgeon
- Able to provide written informed consent
Key exclusion criteria (8 listed)
- Previous failed rotator cuff repair
- Subscapularis pathology
- Goutallier grade III or IV fatty atrophy
- Teres minor tear
- Tendon retraction greater than 22.2 mm [CONFIRM; see issue #4]
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 |
|---|---|---|
| Arthroscopic rotator cuff repair; Biological: Dermis on DemandArthroscopic knotless double-row transosseous-equivalent rotator cuff repair augmented with 2-3 Dermis on Demand acellular dermal allograft pieces loaded onto lateral-row suture tapes | Procedure or surgery | Allograft Augmentation |
| Arthroscopic rotator cuff repairA human acellular dermal allograft (CellRight Technologies) with a cannulated design, loaded onto suture tape and compressed onto the repaired footprint during lateral-row anchor seating. Other names: DOD; acellular dermal allograft. | Procedure or surgery | Standard Repair |
Primary outcome
Rotator cuff retear rate
Time frame: 12 months postoperatively
Proportion of participants with a retear on MRI, defined as Sugaya type IV or V (scale I-V; higher = worse integrity)
10 secondary outcomes
MRI rotator cuff score
Time frame: 12 months
Fatty infiltration
Time frame: 12 months
Ultrasound repair integrity
Time frame: 6 months
ASES score
Time frame: Baseline, 6 wk, 3, 6, 12 months
SANE score
Time frame: Baseline, 6 wk, 3, 6, 12 months
PROMIS Upper Extremity
Time frame: Baseline, 6 wk, 3, 6, 12 months
SF-12
Time frame: Baseline, 6 wk, 3, 6, 12 months
Shoulder range of motion
Time frame: Baseline, 6 wk, 3, 6, 12 months
Shoulder strength
Time frame: Baseline, 6 wk, 3, 6, 12 months
Operative time
Time frame: Day of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Background: PubMed 19213574Goutallier D, Postel JM, Radier C, Bernageau J, Zilber S. Long-term functional and structural outcome in patients with intact repairs 1 year after open transosseous rotator cuff repair. J Shoulder Elbow Surg. 2009 Jul-Aug;18(4):521-8. doi: 10.1016/j.jse.2008.11.006. Epub 2009 Feb 11.
- 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 21098196Crim J, Burks R, Manaster BJ, Hanrahan C, Hung M, Greis P. Temporal evolution of MRI findings after arthroscopic rotator cuff repair. AJR Am J Roentgenol. 2010 Dec;195(6):1361-6. doi: 10.2214/AJR.10.4436.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic rotator cuff repair; Biological: Dermis on Demand and Arthroscopic rotator cuff repair in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by University of Cincinnati at 1 site 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rotator cuff retear rate (time frame: 12 months postoperatively). 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 NCT07890831, which also lists 3 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 22 Oct 2026.