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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Functional Outcomes in Patients Using Knee Brace and Without Knee Brace After Anterior Cruciate Ligament Reconstruction Surgery With Autograft Bone Quadricep Tendon Arthroscopy

Conditions
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Anterior Cruciate Ligament Injuries, Arthroscopy, Braces

Intervention / Treatment
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* Device: Knee Brace


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All patients at Cipto Mangunkusumo Hospital and Gatot Soebroto Hospital, who underwent ACL reconstruction in the period January 2022 - January 2022 who met the inclusion and exclusion criteria.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Knee Brace<br>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 | Device: Knee Brace<br>* Installation of an angle-adjustable knee brace, used after ACL reconstruction performed by an orthopedic specialist or orthopedic PPDS with the first week the angle locked at 00, in the second week the angle 0-900, in the third week the angle 0-1200, and the fourth week the angle of flexion full. Braces are used except for physical therapy according to the rehabilitation protocol in the first week.<br>|
| No Intervention: No Knee Brace<br> | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroscopy, Anterior Cruciate Ligament Injuries, Knee Braces, Functional Outcome