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A study assessing success and failure after knee ligament surgery

A Single center, Observational study to assess Functional Outcomes after Arthroscopic Anterior Cruciate Ligament (ACL) Reconstruction Procedure using Sironix Suture Button and/or Sironix Interference Screw

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/11/047428
Enrollment
60
Registered
2022-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

None listed

Sponsors

Healthium Medtech Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male/female patients aged >=18 to 2. Patients who had undergone arthroscopic ACL reconstruction procedure using Sironix suture button and/or Sironix interference screw between Jan 2019 to July 2022. 3. Patients who are willing to provide written informed consent (in case of physical visit to the site) or verbal informed consent (in case of telephonic visit).

Exclusion criteria

Exclusion criteria: 1. Patients who have suffered traumatic injury to the operated knee post ACL reconstruction procedure. 2. Patients who are not willing to attend the follow-up.

Design outcomes

Primary

MeasureTime frame
To evaluate the functional outcomes after ACL reconstruction procedureTimepoint: One followup after EC approval 3 months to 3.5 years after surgery—

Secondary

MeasureTime frame
1. To evaluate the activity level pre and post ACL Reconstruction Procedure 2. To evaluate the quality of life post ACL Reconstruction Procedure 3. To evaluate the safety of the sironix suture button and/or sironix interference screw in the patients who underwent ACL Reconstruction ProcedureTimepoint: One followup after EC approval 3 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