SINEFIX-2022 Pilot Phase
Rotator Cuff Tears (RCTs)
About this trial
This is an interventional treatment trial for Rotator Cuff Tears (RCTs)
Eligibility Criteria
Inclusion Criteria: Patient indicated for surgical repair of the rotator cuff tear according to current guidelines Patient aged 18 years or older Up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral) Up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior) Exclusion Criteria: Subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder History of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments Inflammatory arthropathies Subject with a contraindication/non-compliance for MRI examination Subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule Pregnant and breastfeeding woman
Sites / Locations
- Orthopädisch Chirurgisches Centrum (OCC)Recruiting
Arms of the Study
Arm 1
Experimental
SINEFIX
Rotator cuff repair with the SINEFIX implant, using the SINEFIX instruments