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A study to assess ooutcomes after knee ligament surgery

A Retrospective, Observational, Post-Marketing Study to Evaluate the Functional Outcomes in Patients Who Underwent Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Using Sironix Suture Button and Interference Screw

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/048128
Enrollment
60
Registered
2022-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M259- Joint disorder, unspecified

Interventions

Intervention1: Not applicable since its a observational retrospective study: Not applicable since its a observational retrospective study Control Intervention1: Not applicable since its a observationa

Sponsors

Healthium Medtech Limited
Lead Sponsor

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 using Sironix suture button and/or interference screw between the period of January 2018 to March 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

MeasureTime frame
To evaluate the function of the knee post ACL reconstructionTimepoint: One followup after EC approval 6 months to 3.5 years after surgery—

Secondary

MeasureTime 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 6 months to 3.5 years after surgery—

Countries

India

Contacts

Public ContactDr Ashok Kumar Moharana

Healthium Medtech Limited

ashok.m@healthiummedtech.com9717887751

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026