A study assessing success and failure after knee ligament surgery
Not Applicable
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/11/047428
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 44
Inclusion Criteria
1. Male/female patients aged >=18 to <=60 years at the time of surgery.
2. Patients who had undergone arthroscopic ACL reconstruction procedure using Sironix suture button and/or Sironix interference screw between Jan 2019 to July 2022.
3. Patients who are willing to provide written informed consent (in case of physical visit to the site) or verbal informed consent (in case of telephonic visit).
Exclusion Criteria
1. Patients who have suffered traumatic injury to the operated knee post ACL reconstruction procedure.
2. Patients who are not willing to attend the follow-up.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the functional outcomes after ACL reconstruction procedureTimepoint: One followup after EC approval 3 months to 3.5 years after surgery
- Secondary Outcome Measures
Name Time Method 1. To evaluate the activity level pre and post ACL Reconstruction Procedure <br/ ><br>2. To evaluate the quality of life post ACL Reconstruction Procedure <br/ ><br>3. To evaluate the safety of the sironix suture button and/or sironix interference screw in the patients who underwent ACL Reconstruction ProcedureTimepoint: One followup after EC approval 3 months to 3.5 years after surgery