Quadrupled Semitendinosus Graft in Anterior Cruciate Ligament Reconstruction

Study Overview
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Brief Summary
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Randomized controlled trial comparing reconstruction of anterior cruciate ligament (ACL) with autologous quadrupled semitendinosus graft or with both semitendinosus and gracilis. It is intended to specially evaluate if by using only the semitendinosus (ST) tendon, the strength of the limb for hamstrings is affected different compared to using both gracilis and ST.

Detailed Description
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Data checks programmed by a third party after inclusion of participant number 10, 20, 30 and 42. This includes source data verification. Simple size calculations estimating a difference of 50% in strength improvement between both groups at the six months follow-up visit. 80% power and 5% alpha error. Strength measured with dynamometer, laxity with ACL laxity tester and function with 3 scores: IKDC, Tegner-Lysholm and KOOS. Missing data will be minimized by double checking when registering data. It might be necessary to increase sample size to 50 patients of intermediate analysis show it is necessary to find an statistically significant difference. Trial could be stopped early if one intervention shows to be better in the intermediate analysis. These analysis will be conducted after the first 16 and 32 participants have been included.

Official Title
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Quadrupled Semitendinosus Graft and Traditional Hamstrings Graft in Anterior Cruciate Ligament Reconstruction: Randomized Controlled Trial

Conditions
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Anterior Cruciate Ligament Injury

Intervention / Treatment
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* Procedure: Quadrupled semitendinosus graft
* Procedure: ST-Gracilis graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with anterior cruciate ligament injury that are candidates for surgical reconstruction with hamstrings. They should be at least 16 years old. Exclusion Criteria: Multiligament injuries. Re-ruptures of the ACL.

Ages Eligible for Study
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Minimum Age: 15 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Quadrupled semitendinosus graft<br>Autologous quadrupled semitendinosus graft is used to reconstruct the ACL injury | Procedure: Quadrupled semitendinosus graft<br>* Quadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.<br>|
| Active Comparator: ST-Gracilis graft<br>Both gracilis and semitendinosus autologous graft are used to reconstruct the ACL injury | Procedure: ST-Gracilis graft<br>* Use of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamstrings Strength | Hamstrings strength measured with a handheld dynamometer (Lafayette model 01165 ). It is measured in Newtons. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior cruciate ligament rerupture | New ACL rupture after the surgical reconstruction. It is evaluated clinically during physical examination. | 24 months | 
| ACL laxity | Grade of laxity after surgery for the ACL. Measured in mm with a knee laxity measurement device (Storz). | 24 months |