Transtibial Versus Anteromedial Femoral Tunnel Technique in ACL Reconstruction

Study Overview
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Brief Summary
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The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Detailed Description
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The anteromedial (AM) portal technique was introduced to position the femoral tunnel in anterior cruciate ligament (ACL) reconstruction to more closely replicate the original footprint compared to the transtibial (TT) approach.1-5 Few randomized trials have evaluated differences in these techniques with respect to clinical outcomes. The purpose of this study was to determine if there are any differences in clinical outcome between the AM and TT approaches.

Official Title
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Prospective Randomized Clinical Study Comparing Anteromedial Portal Versus Transtibial Technique for Femoral Tunnel Positioning in Anterior Cruciate Ligament Reconstruction With Hamstring Autograft

Conditions
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Anterior Cruciate Ligament Reconstruction

Intervention / Treatment
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* Procedure: Femoral tunnel creation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: sustained a complete ACL tear and had no other ligament injuries requiring surgical intervention Exclusion Criteria: concomitant collateral ligament tears significant chondromalacia (based on diagnostic imaging) previous lower limb surgery significant injury to either lower limb requiring surgery history of arthritis were unable to comply with rehabilitation protocols or study follow-ups were pregnant females or had other medical conditions which precluded participation.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transtibial<br>Transtibial technique used to create femoral tunnel | Procedure: Femoral tunnel creation<br>* Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned<br>|
| Active Comparator: Anteromedial<br>Anteromedial technique used to create femoral tunnel | Procedure: Femoral tunnel creation<br>* Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior cruciate ligament quality of life |  | 24-months postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KT-1000 |  | 24-months post-operative | 
| Knee range of motion |  | 24-months post-operative |