Comparative evaluation for arthroscopic rotator cuff repair using biocomposite bioabsorbable anchor and biocompatable synthetic anchor: prospective observational study
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0005290
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
(1) full-thickness rotator cuff tear verified by preoperative magnetic resonance imaging (MRI) or partial-thickness rotator cuff tear refractory to conservative treatment over 6 months; (2) arthroscopic suture bridge repair using both PEEK (4.75mm, CrossFT™ knotless anchor, ConMed, Utica, NY, USA) and biocomposite anchor (70% PLGA/30% ß-TCP, 4.75mm Fix2Lock™, Osteonic, Seoul, South Korea) as a lateral row anchor; (3) availability for MRI evaluation to be taken preoperatively and at 3 and 6 months postoperatively to assess the rotator cuff integrity and status of the anchors; (4) consent to join the study.
(1) History of previous surgical treatment on the affected side wrist, elbow, or shoulder; (2) Infectious, autoimmune, or systemic skeletal disease; (3) Rotator cuff arthropathy or moderate to severe osteoarthritis or Rheumatoid arthritis (n = 4); (4) Unavailability for taking MRI due to implants such as pacemakers; (5) No consent to take part in the study; (6) Lost to follow-up before the second MRI could be taken at 6 months
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the shoulder range of motion, visual analogue scale for pain and satisfactory score, American Shoulder and Elbow Surgeons score, Simple Shoulder Test, perianchor cyst formation on MRI,
- Secondary Outcome Measures
Name Time Method age, gender, occupation, hand dominancy, Initial tear size, Biceps tear, Capsulitis, Goutaliier's stage, Retear on MRI, retear pattern