MedTrace Logo

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

NCT04136990 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-03-22

No results posted yet for this study

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.

Conditions

  • Anterior Cruciate Ligament Injuries

Interventions

PROCEDURE

Isolated ACL reconstruction

Isolated ACL reconstruction using the bone-patellar tendon autograft.

PROCEDURE

ACL + LEAT reconstruction

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

Sponsors & Collaborators

  • Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

    lead OTHER

Principal Investigators

  • João Espregueira-Mendes, MD, PhD · Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-13
Primary Completion
2022-12-31
Completion
2023-06-30

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04136990 on ClinicalTrials.gov