Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital in Indonesia

Study Overview
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Brief Summary
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The study was a prospective observational study analysis of cases having complete ACL tear. Study conduct between February 2021 to December 2023. All the patients attending the emergency or Out Patient Department (OPD) of those hospitals with knee injuries were evaluated for an ACL tear. Patients who meet inclusion criteria and give consent for participation in the study will observe for two years. Patient in Arifin Achmad Hospital Pekanbaru will follow rehabilitation treatment and optional delayed reconstruction after 12 weeks, while patient in Gatot Subroto Army Hospital Jakarta will performed early reconstruction treatment. After taking informed consent, all subjects were provided a self-administered patient questionnaire containing International Knee Documentation Committee (IKDC) score, ACL-RSI, Lysholm, and Tegner Activity Level (TAL) scores. These questionnaires will be measured at 0, 12, 24, 48, and 96 weeks. Besides that, all subjects were provided SF12 for measuring utility value by converting to SF6D. Clinical value of the Lachman test, pivot shift test will be performed. One independent orthopedic surgeon will keep all records and evaluate the results. All costs for the treatment will be accounted for.

Official Title
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Comparison Effectiveness Analysis Between ACL Reconstruction and Rehabilitation in Peripheral and Main Capital of Indonesia

Conditions
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ACL Tear

Intervention / Treatment
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* Procedure: ACL Reconstruction surgery and Rehabilitation Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 to 40 years Either sex Isolated ACL tear not more than 6 weeks old to a previously uninjured knee Tegner Activitiy Level of 5-9. Exclusion criteria Professional athletes or military Collateral ligament rupture Full-thickness cartilage lesion visualized TAL below 5 Meniscal tear grade III on MRI. Pregnancy A history of deep vein thrombosis (DVT) or a disorder of the coagulative system Claustrophobia General systemic disease affecting physical function, any other condition or treatment interfering with the completion of the trial, including patients with metal devices or motion disorders Hyperlaxity with Beighton score more than 4

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACL Reconstruction Group<br>This group received reconstruction treatment in Gatot Subroto Hospital, Jakarta | Procedure: ACL Reconstruction surgery and Rehabilitation Treatment<br>* ACL Reconstruction surgery is a procedure to treat ACL injury by replacing the torn ligament with another. ACL Rehabilitation treatment is a procedure to treat ACL injury by muscle strengthening and exercise<br>|
| Rehabilitation Group<br>This group received rehabilitation treatment with optional delayed reconstruction in Arifin Achmad Hospital, Pekanbaru | Procedure: ACL Reconstruction surgery and Rehabilitation Treatment<br>* ACL Reconstruction surgery is a procedure to treat ACL injury by replacing the torn ligament with another. ACL Rehabilitation treatment is a procedure to treat ACL injury by muscle strengthening and exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Lachman Test | Lachman test was measured by passive movement of the knee at 30 degree of flexion, Grade 1: 3-5mm translation of the tibia Grade 2: 5-10 mm more translation of the tibia Grade 3: translation of the tibia more than 10mm | at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month | 
| Change of Pivot shift test | Pivot shift test was measured by valgus and slowly flexion the knee, Grade 1: gentle twisting slide with tibia twisting internally maximally Grade 2: Clunk with tibia in neutral position Grade 3: painless glide for examiner and patient | at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month | 
| Total cost of treatment | Total cost for surgery treatment or rehabilitation treatment in Rupiah (Indonesian currency). Cost was taken account by direct interview to the patient and direct observation to medical account in the hospital | at 12th month | 
| Change of Questionnaire of International Knee Documentation Committee (IKDC Questionnaire) | IKDC is a subjective patient reported outcome measure for knee specific disease. Scoring in range 0-100, which 0 is lowest score, and 100 is a highest score | IKDC questionnaire was measured at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month | 
| Change of Questionnaire of Short Form-12 (SF-12) | Questionnaire of Short Form-12 (SF-12) is a generic patient reported outcome measure for measuring physical, mental and quality of life of patient according to Ware et al.(1996). Its score ranging from 0 to 100. Higher scores indicate better health status, and a mean score of 50 has been articulated as a normative value for all scales. | SF-12 questionnaire was measured at pre operation (0 month), 3rd month, 6th month, 12th month, 24th month |