A study to assess outcomes after knee ligament surgery

Completed

• Conditions: Joint disorder, unspecified,

• Registration Number: CTRI/2023/05/052392
• Lead Sponsor: Healthium Medtech Limited

Brief Summary

Arthroscopy implants are used for fixation of the ACL grafts at the femoral and tibial sides. Numerous grafts in terms of fixed suture button, adjustable loop suture button, and interference screws made up of multiple materials will be used for the fixation. In this study, we would want to evaluate the functional outcomes in patients who underwent arthroscopic ACL reconstruction using Sironix suture button and Peek button. The available Patient data will be collected and assessed to evaluate the safety and effectiveness of the Sironix knee implant device.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Last Update Posted: 2023-06-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

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 reconstruction	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	2)To assess the quality of life after ACL reconstruction

Trial Locations

Locations (1)

AMRI Hospitals; 🇮🇳 Khordha, ORISSA, India

AMRI Hospitals

🇮🇳Khordha, ORISSA, India

Dr Sunil Kumar Dash

Principal investigator

9776206247

drsunil_dash@yahoo.com