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

March 21, 2022 updated by: Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal, 4350-415
        • Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 23 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 months
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).
Baseline, 12 and 24 months
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).
Baseline, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

October 21, 2019

First Posted (Actual)

October 23, 2019

Study Record Updates

Last Update Posted (Actual)

March 22, 2022

Last Update Submitted That Met QC Criteria

March 21, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0015/0019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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