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

Anterior Cruciate Ligament Injuries Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04136990
• Other study ID #: 0015/0019
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Procedure:
• Isolated ACL reconstruction
Isolated ACL reconstruction using the bone-patellar tendon autograft.
• ACL + LEAT reconstruction
ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.

Locations

Country	Name	City	State
Portugal	Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and 24 months
Secondary	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.	24 months
Secondary	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).	Baseline, 12 and 24 months
Secondary	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).	Baseline, 12 and 24 months