Dermis on Demand Allograft Augmentation for Rotator Cuff Repair

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.

• Arthroscopic rotator cuff repair; Biological: Dermis on Demand (Procedure): 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 repair (Procedure): 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.

Primary outcomes

• Rotator cuff retear rate [12 months postoperatively]: Proportion of participants with a retear on MRI, defined as Sugaya type IV or V (scale I-V; higher = worse integrity)

Secondary outcomes

• MRI rotator cuff score [12 months]: Sum of footprint size, tendon thickness, and signal intensity, each graded 1-4 (Crim et al., 2010). Total range 3-12; 12 = normal tendon.
• Fatty infiltration [12 months]: Goutallier grade 0-4 (higher = more fatty infiltration)
• Ultrasound repair integrity [6 months]: Proportion with intact repair on shoulder ultrasound
• ASES score [Baseline, 6 wk, 3, 6, 12 months]: American Shoulder and Elbow Surgeons score, 0-100 (higher = better)
• SANE score [Baseline, 6 wk, 3, 6, 12 months]: Single Assessment Numeric Evaluation, 0-100% (higher = better)
• PROMIS Upper Extremity [Baseline, 6 wk, 3, 6, 12 months]: T-score, population mean 50, SD 10 (higher = better function)
• SF-12 [Baseline, 6 wk, 3, 6, 12 months]: Physical and Mental Component Summary scores, norm-based, mean 50 (higher = better)
• Shoulder range of motion [Baseline, 6 wk, 3, 6, 12 months]: Forward flexion, abduction, external and internal rotation, in degrees
• Shoulder strength [Baseline, 6 wk, 3, 6, 12 months]: Manual muscle testing, graded 0-5
• Operative time [Day of surgery]: Minutes from incision to closure

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

• 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. PMID 19213574
• 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
• Crim 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. PMID 21098196