Does ACL Augmented With LEAT Better Controls Rotational Laxity Than Isolated ACL Reconstruction?
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|ClinicalTrials.gov Identifier: NCT04136990|
Recruitment Status : Enrolling by invitation
First Posted : October 23, 2019
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment||Phase|
|Anterior Cruciate Ligament Injuries||Procedure: Isolated ACL reconstruction Procedure: ACL + LEAT reconstruction||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Non-randomized 1:1 allocation|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcomes Assessor will be blinded to the patient group|
|Official Title:||Comparison of Anterior Cruciate Ligament Isolated Reconstruction or Combined With Lateral Extra-articular Tenodesis in Knee Laxity, Graft Failure and Patient-reported Outcome Measures|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||June 2023|
Active Comparator: Isolated ACL reconstruction
Isolated ACL reconstruction only.
Procedure: Isolated ACL reconstruction
Isolated ACL reconstruction using the bone-patellar tendon autograft.
Experimental: ACL + LEAT
ACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT).
Procedure: ACL + LEAT reconstruction
ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.
- Change from baseline of sagittal and rotational knee laxity [ Time Frame: Baseline and 24 months ]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).
- Graft Failure [ Time Frame: 24 months ]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.
- Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS) [ Time Frame: Baseline, 12 and 24 months ]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).
- Change from baseline of Tegner Scale [ Time Frame: Baseline, 12 and 24 months ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136990
|Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence|
|Porto, Portugal, 4350-415|
|Study Director:||João Espregueira-Mendes, MD, PhD||Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence|
|Principal Investigator:||Renato Andrade||Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence|