A study to assess outcomes after knee ligament surgery
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/11/047290
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 113
Inclusion Criteria
1. Male/ Female Patients of 18 to 60 years of age.
2. Patients who underwent Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Procedure Using Sironix Suture Button and/or Sironix Interference Screw between the period of April 2018 to July 2022
3. Patient willing to give written informed consent to participate in the study when attending an in-clinic follow-up visit, or providing verbal consent during the telephonic follow-up visit.
Exclusion Criteria
1. Patients not responding to calls after three attempts or not interested to participate in the study.
2. Patients with injury or re-surgery to the same knee post ACL reconstruction procedure.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the function of the knee post ACL reconstructionTimepoint: One followup after EC approval 3 months to 4 years after surgery
- Secondary Outcome Measures
Name Time Method 1. To assess the level of activity pre and post injury <br/ ><br>2. To assess the quality of life after ACL reconstruction <br/ ><br>3. To assess the adverse events associated with knee arthroscopy proceduresTimepoint: One followup after EC approval 3 months to 4 years after surgery