Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT

Study Overview
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Brief Summary
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The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players.

Detailed Description
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A number of techniques for ACL reconstruction have been proposed and tested, and most surgeons now prefer autografts with the patellar tendon or semitendinosus tendon. The functional outcome after ACL reconstruction with the patellar or semitendinosus tendon has been a recent area of interest. Soccer is the most popular sport worldwide with more than 260 million active players, and it is hard to say if patellar tendon or semitendinosus grafts have different outcomes. The purpose of this study was to specifically evaluate outcomes of bone-patellar tendon-bone autograft versus hamstring autograft ACL reconstruction in soccer players. The hypothesis of this study was that hamstring autograft ACL reconstruction would provide no statistically significant differences in patient-reported outcome scores, postoperative level of sports function, and harvest-site morbidity when compared with patellar tendon autograft .The Cincinnati Knee Rating System (CKRS) was chosen as the primary outcome. As secondary outcome, reruptures. Between march 2016 and march 2017, 60 soccer players will be operated. The investigators consider as soccer players those who play more than 4 times a week. Once included in the study, they will be randomized in two groups: hamstring group and patellar tendon group. The final clinical evaluation with two years. For both groups, the technique is the same, the fixation of the grafts with metal interference screws. Femoral tunnel will be drilled with outside-in technique. The tibial tunnel with conventional 55 degrees guide. Both groups of patients will receive the same physical therapy protocol. Data will be evaluated with the SPSS software for Windows (version 13.0).

Official Title
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Hamstrings X Patellar Tendon for Anterior Cruciate Ligament Reconstruction in Soccer Players - RCT

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: Patellar Tendon graft
* Procedure: Hamstring Graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral ACL lesion skeletally mature patients with closed physis no previous surgery on the affected knee (except for arthroscopic meniscectomy) less than 1 year from injury no associated ligament injuries (except for the medial collateral ligament grade I and II) soccer players. Exclusion Criteria: morbid obesity degenerative changes in arthroscopy or image exams those who play soccer less than 4 times / week

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 40 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patellar Tendon Graft<br>Kind of graft that will be used for acl reconstruction | Procedure: Patellar Tendon graft<br>* Acl reconstruction with patellar tendon graft<br>|
| Experimental: Hamstring Graft<br>Kind of graft that will be used for acl reconstruction | Procedure: Hamstring Graft<br>* Acl reconstruction with hamstring graft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cincinnati Knee Rating System | It is a subjective score | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rerupture |  | 2 years | 
| International Knee Documentantion Committee (IKDC) score |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL reconstruction, Single bundle, Clinical results, Soccer players