Trial Details
Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears
NCT03734536
TERMINATED
DESCRIPTION
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.
CONDITIONS
Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
ELIGIBILITY CRITERIA
- 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
