Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical ACL Reconstruction at AM or Central Position

Study Overview
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Brief Summary
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This is a prospective, randomized and double-blind clinical trial about anatomical single-bundle anterior cruciate ligament (ACL) reconstruction. One of the most common causes of ACL reconstruction failure is poor graft positioning. There is evidence that graft placement aligned with native insertion sites results in superior clinical outcomes. Current anatomic ACL reconstruction concepts highlight the importance of the native anatomy to restore physiological knee kinematics more accurately. This study aims to investigate clinical outcomes and dynamic knee stability with force platform and other functional tests after ACL reconstruction in two different groups of tunnel position: anteromedial ACL footprint (AM) or central ACL footprint. It was hypothesized that there would be clinical or dynamic stability differences between AM or Central tunnel groups in ACL reconstruction.

Detailed Description
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Tunnel position will be recorded and confirmed with postoperative computer tomography.

Official Title
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Comparison of Dynamic Knee Stability and Functional Outcomes in Anatomical Single-bundle ACL at Anteromedial or Central Tunnel Position - Prospective, Randomized and Double-blind Clinical Trial in Athletes

Conditions
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Rupture of Anterior Cruciate Ligament, Complete Tear, Knee, Anterior Cruciate Ligament

Intervention / Treatment
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* Procedure: Anatomical ACL reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physical activity classified by Tegner scale ≥ 5 Absence of other associated ligament injuries in the operated knee No ACL rerupture or previous ACL reconstruction in the same or other knee Absence of untreated lesions of the opposite knee No obvious change in the alignment of the mechanical axis that required surgical correction Athletes of both gender with a minimum age of 18 years and maximum of 45 years Signature of the consent term (IRB) Not be pregnant. Exclusion Criteria: Request to stop the study by patient at any time Fracture not associated with the surgical procedure Do not carry out the rehabilitation protocol as oriented by the Sports Medicine group.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 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: AM anatomical ACL reconstruction<br>Femoral and tibial tunnels performed in anteromedial footprint of ACL reconstruction | Procedure: Anatomical ACL reconstruction<br>* Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.<br>* Other names: ACL;|
| Experimental: CENTRAL anatomical ACL reconstruction<br>Femoral and tibial tunnels performed in the center of ACL footprint | Procedure: Anatomical ACL reconstruction<br>* Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.<br>* Other names: ACL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Stability with force platform | Evaluation of dynamic stability in stand position and leg movements with force platform | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline and between groups in Lysholm knee scoring scale | This is a validated scoring scale to evaluate outcomes of knee ligament surgery, particularly symptoms of instability. The total score is the sum of each response to the 8 items, of a possible score of 100. | 6, 12, 24 months | 
| Change from baseline and between groups in Tegner activity score | This is a validated score for level of activity related to knee stability. It provides a standardized method of grading work and sporting activities from 0 to 10. | 6, 12, 24 months | 
| Single leg hop test for distance - side to side difference | This test includes a single leg hop for distance comparison between involved leg vs. contra-lateral normal leg. Results are expressed as a percentage of the non-involved leg. | 6, 12 months | 
| Isokinetic knee strength test - side to side difference | Quadriceps and hamstring isokinetic strength are assessed at velocities of 60 and 240 degrees per second and values are compared between involved operated leg and non-involved leg and between groups. Peak torque and flexion/extension rate are analyzed. | 6, 12 months | 
| Change from baseline and between groups in Dynamic Stability with force platform | Evaluation of dynamic stability in stand position and leg movements with force platform. Antero-posterior and latero-medial movements are measured in metric scale. Area and velocity of movement are also calculated. | 6 months | 
| Change from baseline and between groups in International Knee Documentation Committee form (IKDC) | The form is used to detect improvement or deterioration in symptoms, function, and sports activities due to knee impairment. It is a validated 18-item patient measurement tool. that can be used for post-operatory ACL reconstruction | 6, 12 e 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL, force platform, anterior cruciate ligament, anterior cruciate ligament reconstruction, outcome assessment, outcome assessment, patient, treatment outcome, exercise test, anatomic, anatomical, single-bundle, postural balance, biomechanics, CT scan, X-ray computed tomography, tomography, diagnostic imaging, knee, knee injuries, joint instability, reconstructive surgical procedures, knee surgery, arthroscopy, athletes, sports medicine, humans, prospective studies, Randomized Controlled Trial