Clinical Trial Comparing Three Anterior Cruciate Ligament Reconstructive Procedures

Study Overview
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Brief Summary
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The objective of this prospective study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, bone mineral density and functional status.

Detailed Description
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Anterior cruciate ligament (ACL) reconstruction surgery is one of the common procedures performed by orthopedic surgeons with approximately 100,000 cases performed per year in the United States. A large amount of sports injuries were related to ACL problem. As such, ACL injuries and treatment is still widely under intensive study. Traditionally, ACL surgery has been focused on using bone patella bone graft and single bundle hamstring graft. Problems of knee pain, unstable fixation, rotational instability and degenerative changes were reported. Recently, the use of double bundle hamstring graft to reconstruct the ACL according its anatomy aiming to improve the rotational stability was proposed. However, results about the clinical, functional and radiological outcomes are limited. The objective of this prospective pilot study is to assess the clinical, functional and radiological outcomes of three different ACL reconstruction procedures: Bone Patella Bone graft, Single bundle hamstring graft and anatomical Double bundle graft in terms of pain, swelling, mobility, quadriceps girth size, stability, proprioception, skin sensation, bone mineral density and functional status. Subjects to be operated for ACL reconstruction and meeting the inclusion and exclusion criteria will be recruited. Subjects will be randomly assigned to the three surgical groups by block randomization. Demographic information, parameters in recovery domain, functional domain and stability domain, isokinetic test, motion analysis domain, proprioception and radiographical measurements will be made at baseline and at day 1, week 2, week 4, week 8, month 3, month 5, 1 year and 2 years post-surgery. The effect of different surgical techniques and time on the different outcomes will be analysed by 2-way ANOVA.

Official Title
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Functional, Clinical & Radiological Outcome of Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Control Clinical Trial Studies Comparing Bone Patella Bone, Single Bundle and Double Bundle Method.

Conditions
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Knee Injuries

Intervention / Treatment
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* Procedure: Single bundle hamstring
* Procedure: Double bundle hamstring
* Procedure: Bone patellar tendon bone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men above age 18-40 years old First ACL reconstruction surgery Single leg involvement Exclusion Criteria: ACL injury less than 6 weeks as deleterious effect of the injury may affect the extension range Injury on Duty (IOD) cases Other associated injuries (Fractures, other ligaments involvement, neurovascular bundles injury),Chondral lesion with co-commitment intervention Concomitant meniscus repair in same operation, or within 3 months before the operation Significant OA changes Known chronic disease or receiving long term medications affecting bone metabolism, including anabolic steroids, medication for thyroid hormone therapy or osteoporosis Neurological deficit

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

Sexes Eligible for Study
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Male

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single bundle hamstring<br> | Procedure: Single bundle hamstring<br>* Single bundle hamstring<br>|
| Experimental: Double bundle hamstring<br> | Procedure: Double bundle hamstring<br>* Double bundle hamstring<br>|
| Active Comparator: Bone patellar tendon bone<br> | Procedure: Bone patellar tendon bone<br>* Bone patellar tendon bone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Knee Documentation Committee (IKDC)Knee Form 2000 Score | It is a score on a scale from 0 to 100. It is a knee-specific measure of symptoms, function and sports activity of subjects based on self-report. 0 represents the worst while 100 represents the best score. The higher the score, the better the knee function. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Distal Femoral Bone Mineral Density (BMD)Decrease | % BMD decrease of distal femur of injured side with reference to the BMD at day 1 after surgery | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior cruciate ligament rupture, Anterior cruciate ligament(A02.513.514.100)