Comparison of Early Versus Delay Reconstruction in Anterior Cruciate Ligament Tearing

Study Overview
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Brief Summary
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The purpose of this study is to determine which surgical method is better for anterior cruciate ligament teas in outcomes.

Detailed Description
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The anterior cruciate ligament (ACL) is one of the most commonly injured ligaments of the knee. This study was conducted to determine whether the outcome of treatment is superior in early surgical reconstruction compared with optional delay reconstruction.

Official Title
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Study of Surgical Methods for Anterior Cruciate Ligament Tearing

Conditions
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Anterior Cruciate Ligament Tear

Intervention / Treatment
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* Procedure: early reconstruction
* Procedure: delay reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a. patients with confirmed anterior cruciate ligament tearing Exclusion Criteria: One of the following associated injuries to the index knee as visualized on MRI and/or arthroscopy: An unstable longitudinal meniscus tear that requires repair and where the following postoperative treatment (i.e. bracing and limited ROM) interferes with the rehabilitation protocol Bi-compartmental extensive meniscus resections A cartilage injury representing a full thickness loss down to bone A total rupture of MCL/LCL as visualized on MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 36 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: early<br>patients underwent < 8 weeks reconstruction after injury | Procedure: early reconstruction<br>* patients underwent < 8 weeks reconstruction after injury<br>|
| Other: delay<br>patients underwent > 8 weeks reconstruction after injury | Procedure: delay reconstruction<br>* patients underwent > 8 weeks reconstruction after injury<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | SF-36 questionnaire consists of 36 questions (two main components: physical and mental), each of which was assigned a score ranging from 0 to 100. | at 6 months post-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tegner activity score | The Tegner Activity Scale depicts the level of sporting activity and allows us to compare and document the preinjury activity level with the present activity level. This numeric score ranging from 1 to 10 where 1 is the least strenuous activity for the knee and 10 is the hardest. | at 6 months post-operatively | 
| Knee injury and Osteoarthritis Outcome Score | The Knee injury and Osteoarthritis Outcome Score is the extended form of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) with 42 - items in 5 subscales consisting : pain ( 9 items ) , other symptoms ( 7 items ) , activities of daily living ( 17 items ) , sports and recreational function ( sport / rec ) ( 5 items ) , and knee - related quality of life ( QOL ) ( 4 items ) . | at 6 months post-operatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament,Early,Delay,Reconstruction