CTRI/2021/09/036704
Active, Not Recruiting
Phase 4
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
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: M668- Spontaneous rupture of other tendons
- Sponsor
- Healthium Medtech Limited
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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