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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2023-06-30

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.

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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.

Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Non-randomized 1:1 allocation

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes Assessor will be blinded to the patient group

Study Groups

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Isolated ACL reconstruction

Isolated ACL reconstruction only.

Group Type ACTIVE_COMPARATOR

Isolated ACL reconstruction

Intervention Type PROCEDURE

Isolated ACL reconstruction using the bone-patellar tendon autograft.

ACL + LEAT

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

Group Type EXPERIMENTAL

ACL + LEAT reconstruction

Intervention Type PROCEDURE

ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.

Interventions

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Isolated ACL reconstruction

Isolated ACL reconstruction using the bone-patellar tendon autograft.

Intervention Type PROCEDURE

ACL + LEAT reconstruction

ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.

Intervention Type PROCEDURE

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)

Minimum Eligible Age

15 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No