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

Not Applicable

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Procedure: Isolated ACL reconstruction; Procedure: ACL + LEAT reconstruction

• Registration Number: NCT04136990
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2020-01-13
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-21
• Last Update Posted: 2022-03-22
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isolated ACL reconstruction	Isolated ACL reconstruction	Isolated ACL reconstruction only.
ACL + LEAT	ACL + LEAT reconstruction	ACL reconstruction combined with Lateral Extra-Articular Tenodesis (LEAT).

Primary Outcome Measures

Name	Time	Method
Change from baseline of sagittal and rotational knee laxity	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

Name	Time	Method
Graft Failure	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.
Change from baseline of Tegner Scale	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).
Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS)	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).

Trial Locations

Locations (1)

Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence; 🇵🇹 Porto, Portugal