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

Primary Purpose

Anterior Cruciate Ligament Injuries

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Isolated ACL reconstruction
ACL + LEAT reconstruction
Sponsored by
Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Cruciate Ligament Injuries focused on measuring Anterior Cruciate Ligament Reconstruction, Lateral Extra-Articular Tenodesis, Knee Laxity, Porto Knee Testing Device

Eligibility Criteria

15 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Isolated ACL reconstruction

ACL + LEAT

Arm Description

Isolated ACL reconstruction only.

ACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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).
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).

Full Information

First Posted
October 18, 2019
Last Updated
March 21, 2022
Sponsor
Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
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1. Study Identification

Unique Protocol Identification Number
NCT04136990
Brief Title
Does ACL Augmented With LEAT Better Controls Rotational Laxity Than Isolated ACL Reconstruction?
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
Keywords
Anterior Cruciate Ligament Reconstruction, Lateral Extra-Articular Tenodesis, Knee Laxity, Porto Knee Testing Device

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomized 1:1 allocation
Masking
Outcomes Assessor
Masking Description
Outcomes Assessor will be blinded to the patient group
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isolated ACL reconstruction
Arm Type
Active Comparator
Arm Description
Isolated ACL reconstruction only.
Arm Title
ACL + LEAT
Arm Type
Experimental
Arm Description
ACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT).
Intervention Type
Procedure
Intervention Name(s)
Isolated ACL reconstruction
Intervention Description
Isolated ACL reconstruction using the bone-patellar tendon autograft.
Intervention Type
Procedure
Intervention Name(s)
ACL + LEAT reconstruction
Intervention Description
ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.
Primary Outcome Measure Information:
Title
Change from baseline of sagittal and rotational knee laxity
Description
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).
Time Frame
Baseline and 24 months
Secondary Outcome Measure Information:
Title
Graft Failure
Description
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.
Time Frame
24 months
Title
Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS)
Description
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).
Time Frame
Baseline, 12 and 24 months
Title
Change from baseline of Tegner Scale
Description
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).
Time Frame
Baseline, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Espregueira-Mendes, MD, PhD
Organizational Affiliation
Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Renato Andrade
Organizational Affiliation
Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
City
Porto
ZIP/Postal Code
4350-415
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No

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

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