Health Condition 1: O- Medical and Surgical
Conditions
Interventions
None listed
Sponsors
Healthium Medtech Limited
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the function of the knee post ACL reconstructionTimepoint: One followup after EC approval 3 months to 4 years after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the level of activity pre and post injury 2. To assess the quality of life after ACL reconstruction 3. To assess the adverse events associated with knee arthroscopy proceduresTimepoint: One followup after EC approval 3 months to 4 years after surgery | — |
Countries
India
Contacts
Public ContactDr Laxman Jakkala
Healthium Medtech Limited
Outcome results
None listed