Stopped: Business reasons not related to patient safety
United States168 participantsStarted 2018-12-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. Failed conservative medical management of the tendon tear defined as:
✓. Four (4) to six (6) weeks of formal physical therapy or guided home exercises
✓. Activity modification
✓. Shoulder injection at the discretion of the surgeon
✓. Able to comply with the post-operative physiotherapy and follow-up schedule
✓. Able to speak and read English Provide written informed consent
Exclusion criteria
✕. Prior shoulder surgery on index shoulder within 12 months of enrollment
✕. Failed primary rotator cuff surgery of the index shoulder
✕. On steroids within 1 month of enrollment
✕. Metastatic disease
✕. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)