Functional Outcomes Comparison in Patients Using Knee Brace Post ACL Reconstruction With Autograft Bone Quadricep Tendon

Not Applicable

• Conditions: Braces; Anterior Cruciate Ligament Injuries; Arthroscopy
• Interventions: Device: Knee Brace

• Registration Number: NCT05457452
• Lead Sponsor: Indonesia University

Brief Summary

This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy.

Detailed Description

This study is a study looking for the relationship between variables with a prospective cohort design to determine functional outcomes subjectively and objectively in patients with and without braces after ACL reconstruction with bone quadriceps tendon per arthroscopy.

The research will be conducted at the National Central General Hospital dr. Cipto Mangunkusumo, Jakarta Police Hospital and Gatot Soebroto Army Hospital in Jakarta, Indonesia.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-11
• Last Update Submitted: 2022-07-11
• Study First Posted: 2022-07-14
• Last Update Posted: 2022-07-14
• Study Start: 2022-08-01
• Primary Completion: 2023-02-01
• Study Completion: 2023-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Adult patients with age more than equal to 18 years
• Patients with ACL rupture without other ligament ruptures undergoing ACL reconstruction
• Patients undergoing ACL reconstruction using Quadricep Tendon Autograft

Exclusion Criteria

• Patients with hyperlaxity
• Patients with previous history of ACL reconstruction
• Patients with recurrent rupture during the observation period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Knee Brace	Knee Brace	Use of a Knee Brace after ACL Reconstruction, the patient is put on a knee brace by an orthopedic doctor or orthopedic resident after ACL reconstruction

Primary Outcome Measures

Name	Time	Method
Lysholm score 3 months post treatment	3 months	Patients were interviewed by the examiner based on the questions in the Lysholm form. Scale from 0 to 100. Higher score means better clinical outcomes
International Knee Documentation Committee (IKDC) score 6 months post treatment	6 months	Patients were interviewed by the examiner based on questions in the International Knee Documentation Committee (IKDC) form. Scale from 0 to 100. Higher score means better clinical outcomes
Lysholm score 6 months post treatment	6 months	Patients were interviewed by the examiner based on the questions in the Lysholm form. Scale from 0 to 100. Higher score means better clinical outcomes
Knee injury and Osteoarthritis Outcome (KOOS) score 3 months post treatment	3 months	The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes
Knee injury and Osteoarthritis Outcome (KOOS) score 6 months post treatment	6 months	The patient was interviewed by the examiner according to the KOOS Questionnaire form. Scale from 0 to 100. Higher score means better clinical outcomes
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 6 months post treatment	6 months	Patients were interviewed by the examiner based on the questions on the Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) form. Scale from 0 to 100. Higher score means better clinical outcomes
International Knee Documentation Committee (IKDC) score 3 months post treatment	3 months	Patients were interviewed by the examiner based on questions in the International Knee Documentation Committee (IKDC) form. Scale from 0 to 100. Higher score means better clinical outcomes
Rolimeter 3 months post treatment	3 months	Objective examination of knee stability using a rolymeter
Rolimeter 6 months post treatment	6 month	Objective examination of knee stability using a rolymeter
Anterior Cruciate Ligament Return to Sport after Injury (ACL-RSI) score 3 months post treatment	3 months	Patients were interviewed by the examiner based on the questions on the Anterior Cruciate Ligament Return to Sport After Injury (ACL-RSI) form. Scale from 0 to 100. Higher score means better clinical outcomes

Trial Locations

Locations (1)

Department of Orthpaedic and Traumatology RSCM-FKUI; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia