A study to assess the results after knee ligament surgery
Phase 4
Completed
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2022/11/047339
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 33
Inclusion Criteria
1. Male and female patients aged between 18 to 60 years at the time of surgery
2. Patients who underwent ACL reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIX between April 2018 to July 2022
3. Patients who have provided verbal consent or written informed consent (if subject visits the site) to participate in the study
Exclusion Criteria
1. Unable to provide verbal consent or written informed consent and unwilling to be followed up telephonically
2. Patients who have suffered traumatic injury after surgery affecting the operated knee
3. Patients who are unable to move/walk due to critical illness other than operated knee complications
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the functional outcomes following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIX.Timepoint: One followup after EC approval 3 months to 3.5 years after surgery
- Secondary Outcome Measures
Name Time Method 1. To evaluate any complications following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIX <br/ ><br>2. To evaluate the activity level following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIXTimepoint: One followup after EC approval 3 months to 3.5 years after surgery