A study to assess the results after knee ligament surgery

A retrospective observational study on functional outcomes following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or interference screw of SIRONIX

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/11/047339

Enrollment

Registered

2022-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and female patients aged between 18 to 60 years at the time of surgery 2. Patients who underwent ACL reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIX between April 2018 to July 2022 3. Patients who have provided verbal consent or written informed consent (if subject visits the site) to participate in the study

Exclusion criteria

Exclusion criteria: 1. Unable to provide verbal consent or written informed consent and unwilling to be followed up telephonically 2. Patients who have suffered traumatic injury after surgery affecting the operated knee 3. Patients who are unable to move/walk due to critical illness other than operated knee complications

Design outcomes

Primary

Measure	Time frame
To evaluate the functional outcomes following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIX.Timepoint: One followup after EC approval 3 months to 3.5 years after surgery	—

Secondary

Measure	Time frame
1. To evaluate any complications following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIX 2. To evaluate the activity level following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIXTimepoint: One followup after EC approval 3 months to 3.5 years after surgery	—

Measure

Time frame

1. To evaluate any complications following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIX 2. To evaluate the activity level following arthroscopic Anterior Cruciate Ligament (ACL) reconstruction using loop suture button and/or HELYSIS interference screw of SIRONIXTimepoint: One followup after EC approval 3 months to 3.5 years after surgery

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Countries

India

Contacts

Public ContactDr Ashok Kumar Moharana

Healthium Medtech Limited

ashok.m@healthiummedtech.com9717887751

Outcome results