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Comparative evaluation for arthroscopic rotator cuff repair using biocomposite bioabsorbable anchor and biocompatable synthetic anchor: prospective observational study

omparative evaluation for Arthroscopic Rotator Cuff Repair Using Poly Lactic-co-glycolic Acid Plus -tricalcium Phosphate((PLGA +B-TCP) Biocomposite Bio-Anchors vs Polyetheretherketone (PEEK) Bio-Anchor : Prospective observational study.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0005290
Enrollment
40
Registered
2020-08-04
Start date
2020-03-01
Completion date
Unknown
Last updated
2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Hallym University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
age, gender, occupation, hand dominancy, Initial tear size, Biceps tear, Capsulitis, Goutaliier's stage, Retear on MRI, retear pattern

Countries

Korea, Republic of

Contacts

Public ContactYong-Beom Lee

Hallym University Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026