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临床试验/KCT0005290
KCT0005290已完成未知

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.

Hallym University Medical Center0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
40

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational Study

入排标准

年龄范围
27(Year) 至 74(Year)(—)
性别
All

入选标准

  • (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.

排除标准

  • (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

研究者

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