Treatment of Partial-Thickness Rotator Cuff Tears
Purpose
Demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears because REGENETEN preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery.
Condition
- Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Other REGENETEN™ Bioinductive Implant |
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system. |
|
Other Arthroscopic repair of the high-grade (>50%) partialthickness |
Surgical treatment of partial-thickness rotator cuff tears using standard techniques. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03734536
- Status
- Terminated
- Sponsor
- Smith & Nephew, Inc.
Detailed Description
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.