A study to assess outcomes after knee ligament surgery
Not Applicable
Completed
- Conditions
- Health Condition 1: M259- Joint disorder, unspecified
- Registration Number
- CTRI/2023/05/052392
- Lead Sponsor
- Healthium Medtech Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
Inclusion Criteria
1.Male/ Female Patients of 18 to 60 years of age.
2.Patients who underwent arthroscopic anterior cruciate ligament (ACL) reconstruction using the Sironix suture button and Peek Button between the period of August 2022 to January 2023.
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 and not interested to participate in the study.
2.Patients with injury 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 follow up after EC approval 6months to 3.5 years after surgery
- Secondary Outcome Measures
Name Time Method 1)To assess the level of activity post ACL reconstruction <br/ ><br>2)To assess the quality of life after ACL reconstruction <br/ ><br>3)To assess the adverse events associated with knee arthroscopy procedures <br/ ><br>Timepoint: One follow up after EC approval 6months to 3.5 years after surgery