Does ACL Augmented With LEAT Better Controls Rotational Laxity Than Isolated ACL Reconstruction?

Study Overview
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Brief Summary
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It has been suggested that adding a Lateral Extra-Articular Tenodesis (LEAT) to Anterior Cruciate Ligament (ACL) reconstruction has the advantage of better controlling the rotational laxity. The objective of this study is to compare the the sagittal and rotational knee laxity using the Porto Knee Testing Device (PKTD) - a MRI-compatible arthrometer - at 2 years follow-up (side-to-side and to baseline comparison) in patients that underwent isolated ACL reconstruction (isolated ACL) versus ACL reconstruction combined with LEAT (ACL+LEAT). Patient-reported outcome measures using the Knee Injury and Osteoarthritis Outcome Score (KOOS) and graft failure (re-tear) will also be assessed at 2 years follow-up.

Detailed Description
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This study is a non-randomized clinical trial including 40 patients with anterior cruciate ligament injury who are undergoing surgery and will be allocated 1:1 to either isolated ACL reconstruction (control group) or ACL reconstruction combined with lateral extra-articular tenodesis (experimental group). The principal outcome of this work is the sagittal and rotational knee laxity analysis and side-to-side and 2-year improvement. The secondary outcomes include graft failure (re-tears) and the patient-reported outcome measures (KOOS) at 2 years follow-up.

Official Title
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Comparison of Anterior Cruciate Ligament Isolated Reconstruction or Combined With Lateral Extra-articular Tenodesis in Knee Laxity, Graft Failure and Patient-reported Outcome Measures

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Procedure: Isolated ACL reconstruction
* Procedure: ACL + LEAT reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: no previous knee surgeries contralateral healthy knee positive pivot-shift (++) Exclusion Criteria: revision ACL surgery ACL reconstruction using allograft or synthetic grafts multi-ligament injury pregnant female other injuries or conditions that may alter the knee function (eg. severe osteoarthritis) requiring concomitant osteotomy requiring concomitant cartilage surgery (other than debridement)

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomized 1:1 allocation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Isolated ACL reconstruction<br>Isolated ACL reconstruction only. | Procedure: Isolated ACL reconstruction<br>* Isolated ACL reconstruction using the bone-patellar tendon autograft.<br>|
| Experimental: ACL + LEAT<br>ACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT). | Procedure: ACL + LEAT reconstruction<br>* ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of sagittal and rotational knee laxity | To assess the post-operative knee sagittal and rotational laxity, we will use the Porto Knee Testing Device (PKTD). We will measure the anterior displacement on the medial and lateral plateaus and internal and external rotation in the lateral and medial plateau. Additionally, these measures will be combined to measure the anterior global translation (anterior translation on lateral + medial plateaus) and the global rotation (internal + external rotation in the lateral plateau). | Baseline and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft Failure | Rate of graft failure. It will be considered only graft tears. We will determine the absolute risk of graft failure in each group, if enough data available. | 24 months | 
| Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS) | The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sports/recreation (5 items) and knee-related quality of life (4 items). Domain scores represent the average of all items in the domain standardized to a score from 0 to 100 (worst to best). | Baseline, 12 and 24 months | 
| Change from baseline of Tegner Scale | The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10, developed for knee injuries (especially ACL injury). | Baseline, 12 and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cruciate Ligament Reconstruction, Lateral Extra-Articular Tenodesis, Porto Knee Testing Device, Knee Laxity