CTRI/2021/09/036704进行中（未招募）4 期
Single-blind, randomized study evaluating clinical equivalence of Clinifibre® (Healthium) and FiberWire® (Arthrex) ultra-high-molecular-weight polyethylene (UHMWPE) suture for graft preparation, in patients undergoing arthroscopic unilateral primary Anterior Cruciate Ligament (ACL) Reconstruction
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Skeletally mature subjects of both gender aged 18-50 years undergoing Unilateral Primary ACL Reconstruction
- •2. Subjects requiring ultra-high-molecular-weight polyethylene (UHMWPE) suture for hamstring autograft preparation
- •3. Subject having contralateral healthy knee on clinical examination
- •4. Subject with physical activity classified by Tegner scale = 1
- •5. Subject who has given written informed consent
排除标准
- •1. Subject with body mass index <18.5 or >30 kg/m2
- •2. Subject undergoing ACL reconstruction using bone-patellar tendon-bone graft
- •3. Subject who is a professional athlete
- •4. Subject with HbA1c more than 10
- •5. Subject who is a heavy smoker i.e., smoking = 20 cigarettes per day
- •6. Subject having posterior crutiate ligament injury, or other collateral ligament injury
- •7. Subject having obvious change in the alignment of the mechanical axis requiring surgical correction (Varus or Valgus malalignment greater than 3 degrees)
- •8. Subject having generalized ligamentous laxity (Beighton score of 4 or greater or defined as the simultaneous presence of joint hypermobility at the four limbs and axial skeleton, with involvement of both the major and minor joints)
- •9. Subject with history of bleeding disorder, connective tissue disorder or congenital disease that predispose a patient for articular cartilage damage
- •10. Subject not achieving 90° of flexion in the affected knee before surgery.
- •11. Subject having osseous fractures or trauma that could impair rehabilitation and/or ACL repair.
- •12. Subject who is pregnant
- •13. Subject with history of allergy to polyethylene or similar products
- •14. Subject who is already participating in another trial or have received an experimental drug or have used an experimental medical device within 30 days prior to the planned start of procedure
- •15. Subject unlikely to comply with surgical procedure, rehabilitation protocol or complete the scheduled follow up visit, in the opinion of investigator
- •16. Employee of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
- •17. Other indication-based exclusion, in opinion of investigator
研究者
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