Clinical trial NCT04136990: Does ACL Augmented With LEAT Better Controls Rotational Laxity Than Isolated ACL Reconstruction?
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Keywords: Anterior Cruciate Ligament Reconstruction
Lateral Extra-Articular Tenodesis
Knee Laxity
Porto Knee Testing Device
Lead sponsor: Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomized 1:1 allocation
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change from baseline of sagittal and rotational knee laxity
timeFrame: Baseline and 24 months
Secondary outcomes:
measure: Graft Failure
timeFrame: 24 months
measure: Change from baseline of Knee Osteoarthritis and Outcomes Score (KOOS)
timeFrame: Baseline, 12 and 24 months
measure: Change from baseline of Tegner Scale
timeFrame: Baseline, 12 and 24 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
Study officials:
affiliation: Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
name: João Espregueira-Mendes, MD, PhD
role: STUDY_DIRECTOR
affiliation: Clínica do Dragão, Espregueira-Mendes Sports Centre - FIFA Medical Centre of Excellence
name: Renato Andrade
role: PRINCIPAL_INVESTIGATOR
References: