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

Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence

Status: Unknown

Conditions: Anterior Cruciate Ligament Injuries

Treatments: Procedure: ACL + LEAT reconstruction; Procedure: Isolated ACL reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT04136990

0015/0019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15 to 25 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Isolated ACL reconstruction

Active Comparator group

Description:

Isolated ACL reconstruction only.

Treatment:

Procedure: Isolated ACL reconstruction

ACL + LEAT

Experimental group

Description:

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

Treatment:

Procedure: ACL + LEAT reconstruction