CTRI/2023/04/051727
Active, not recruiting
Phase 4
A Prospective, Multicentric, Single-arm Study to evaluate the effectiveness and safety in Patients undergoing Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Procedure using Fixed Loop UHMWPE Suture Titanium Button and Titanium Interference Screw.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Health Condition 1: - Health Condition 2: M999- Biomechanical lesion, unspecified
- Sponsor
- Healthium Medtech Limited
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male and female subjects between 18 to 45 years of age.
- •2\.Subjects with ACL injury with or without associated meniscus injuries requiring primary ACL reconstruction surgery.
- •3\.Subject willing to give written informed consent to participate in the study.
Exclusion Criteria
- •1\.Subjects with Posterior Cruciate Ligament injury, and/or Collateral ligament injury.
- •2\.Subjects with known hypersensitivity to titanium and/or UHMWPE suture.
- •3\.Subjects with BMI \=35 kg/m2
- •4\.Subjects with a history of previous knee surgery
- •5\.Subjects with the insufficient quantity or skeletally immature bone.
- •6\.Subjects with active infection or blood supply limitations.
- •7\.Subjects with pathological conditions of the bone or soft tissues that would impair secure fixation.
- •8\.Subjects with conditions, which would limit the subject’s ability or willingness to restrict activities or follow directions during the healing period.
- •9\.Subjects having any condition that could affect healing (Infections, regular use of Corticosteroids, Diabetes – HbA1C \= 10\).
- •10\.Subjects with a history of heavy smoking ( \> 20 cigarettes/day) within the last 6 months.
Outcomes
Primary Outcomes
Not specified
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