Treatment of Partial-Thickness Rotator Cuff Tears

Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.

The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.

Inclusion Criteria:

Patients will be considered qualified for enrollment if they meet the following criteria:

1. Male or female ≥18 years

2. High-grade (>50% tendon thickness) partial-thickness tear

3. Failed conservative medical management of the tendon tear defined as:

   1. Four (4) to six (6) weeks of formal physical therapy or guided home exercises
   2. Activity modification
   3. Shoulder injection at the discretion of the surgeon

4. Able to comply with the post-operative physiotherapy and follow-up schedule

5. Able to speak and read English Provide written informed consent

Exclusion Criteria:

Any one (1) of the following criteria will disqualify a patient from participation in the study:

1. Prior shoulder surgery on index shoulder within 12 months of enrollment
2. Failed primary rotator cuff surgery of the index shoulder
3. On steroids within 1 month of enrollment
4. Metastatic disease
5. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
6. Concomitant biceps tenodesis
7. Rheumatoid arthritis
8. Advanced osteoarthritis
9. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
10. Chronic pain disorders (i.e., fibromyalgia)
11. History of insulin dependent diabetes
12. History of heavy smoking (> 1 pack per day) within 6 months of enrollment
13. Currently involved in any injury litigation or workers compensation claims
14. Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study