A study to assess result after knee surgery
- Conditions
- Health Condition 1: - Health Condition 2: M999- Biomechanical lesion, unspecified
- Registration Number
- CTRI/2023/04/051727
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
11.Subjects with a medical or physical condition that, in the opinion of the investigator, would preclude safe subject participation in the study.
12.Subjects who are pregnant or lactating at the time of screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the functional outcomes of the knee after ACL Reconstruction surgery from baseline to 24 months post-surgeryTimepoint: Screening, 3 months post-surgery, 6 months post-surgery, 12 months post-surgery, 18 months post-surgery, and 24 months post-surgery
- Secondary Outcome Measures
Name Time Method