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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
Sponsor:
Information provided by (Responsible Party):
Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anterior Cruciate Ligament Injuries Procedure: Isolated ACL reconstruction Procedure: ACL + LEAT reconstruction Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).



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Ages Eligible for Study:   15 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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


Locations
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Portugal
Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Porto, Portugal, 4350-415
Sponsors and Collaborators
Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Investigators
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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

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Responsible Party: Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
ClinicalTrials.gov Identifier: NCT04136990    
Other Study ID Numbers: 0015/0019
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence:
Anterior Cruciate Ligament Reconstruction
Lateral Extra-Articular Tenodesis
Knee Laxity
Porto Knee Testing Device
Additional relevant MeSH terms:
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Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries