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A study to assess outcomes 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 Peek Button.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/05/052392
Enrollment
30
Registered
2023-05-09
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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 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

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
1)To assess the level of activity post ACL reconstruction 2)To assess the quality of life after ACL reconstruction 3)To assess the adverse events associated with knee arthroscopy procedures Timepoint: One follow up after EC approval 6months 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