An interventional study of Arthroscopic rotator cuff repair; Biological: Dermis on Demand and Arthroscopic rotator cuff repair in Rotator Cuff Tears and Rotator Cuff Injuries, sponsored by University of Cincinnati. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of Cincinnati · Not applicable, Interventional, and Treatment
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.
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.
745 studies on the registry are indexed under Rotator Cuff Injuries; 163 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 547 interventional studies indexed under Rotator Cuff Injuries.
Browse Rotator Cuff Injuries studies →University of Cincinnati is the lead sponsor of 324 studies on the registry; 42 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 15 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Procedure: Arthroscopic rotator cuff repair; Biological: Dermis on Demand
Identical arthroscopic knotless double-row transosseous-equivalent repair construct without allograft
Procedure: Arthroscopic rotator cuff repair
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
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.
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)
Time frame: 12 months postoperatively
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.
Time frame: 12 months
Fatty infiltration
Goutallier grade 0-4 (higher = more fatty infiltration)
Time frame: 12 months
Ultrasound repair integrity
Proportion with intact repair on shoulder ultrasound
Time frame: 6 months
ASES score
American Shoulder and Elbow Surgeons score, 0-100 (higher = better)
Time frame: Baseline, 6 wk, 3, 6, 12 months
SANE score
Single Assessment Numeric Evaluation, 0-100% (higher = better)
Time frame: Baseline, 6 wk, 3, 6, 12 months
PROMIS Upper Extremity
T-score, population mean 50, SD 10 (higher = better function)
Time frame: Baseline, 6 wk, 3, 6, 12 months
SF-12
Physical and Mental Component Summary scores, norm-based, mean 50 (higher = better)
Time frame: Baseline, 6 wk, 3, 6, 12 months
Shoulder range of motion
Forward flexion, abduction, external and internal rotation, in degrees
Time frame: Baseline, 6 wk, 3, 6, 12 months
Shoulder strength
Manual muscle testing, graded 0-5
Time frame: Baseline, 6 wk, 3, 6, 12 months
Operative time
Minutes from incision to closure
Time frame: Day of surgery
Plan to share: No
Ran from Dec 2021 to primary completion in May 2026, 53 months.
Of 284 non-industry interventional studies with no phase under Rotator Cuff Injuries, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 37. This study's 53 months is above that.
Counting every sponsor, half of 306 studies reached it within 19 months; a quarter within 9 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.