Clinical trial NCT04373408: ALL Ultrasound Predicts the Success of ACL Repair?
Official title: Does Anterolateral Ligament Ultrasound Influences the Return-to-play After Anterior Cruciate Ligament Rupture? Survival Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anterior Cruciate Ligament Rupture
Surgery
Keywords: Anterior Cruciate Ligament Rupture
Anterolateral ligament
Ultrasonography
Lead sponsor: Hôpital de la Providence, Switzerland
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ACL rupture

Brief summary: This case series evaluates whether patients with an anterior cruciate ligament (ACL) repair have better outcome if the anterolateral ligament (ALL) was repaired or not considering the ultrasound (US) pre-surgical recommendation.

Detailed description: In this case series, the surgeon will decide which patient will have ACL only or ACL and ALL surgery on the basis on multiple parameters. All patient will undergo detailed pre-clinical evaluation, including an ultrasonographic evaluation of the integrity of the ALL.

Two subgroups will be compared for the primary outcome (International Knee Documentation Committee score at 8 months of follow-up). In subgroup 1, the surgeon will follow the ultrasonographic evaluation of the ALL considering the ALL repair (i.e. : ALL intact on the ultrasound, ACL repair only; ALL broken on ultrasound; ACL and ALL repair). In subgroup 2, the surgeon will not follow the ultrasonographic evaluation of the ALL considering the ALL repair.

Secondary outcomes of interest will be evaluated with multivariate regression analysis.

Sample size calculation:

The chosen parameter of interest for the primary outcome evaluation is a continuous response variable (IKDC score) from two independent subgroups (ultrasonographic evaluation of the ALL followed or not for the surgical repair), considering a ratio of 1:3 between the two subgroups. In a previous study (AJSM Sonnery-Cottet 2017) the response within each subject group was normally distributed with standard deviation 13.1. If the true difference between the group means is the published minimal clinically important difference of 9 (AJSM Nwachukwu 2017), we will need to study 30 experimental subjects and 90 control subjects to be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) 0.9. The Type I error probability associated with this test of this null hypothesis is 0.05.

Eligibility criteria: Inclusion Criteria:

* Patients with an ACL rupture and pre-surgical ultrasound evaluation

Exclusion Criteria:

* Sedentary patient without sports activities
* Prior ACL rupture of the same knee
* Posterior cruciate ligament rupture

Primary outcomes:
measure: IKDC score
timeFrame: Month 8
Secondary outcomes:
measure: IKDC score
timeFrame: Months 0, 2, 5, 12
measure: Lysholm score
timeFrame: Months 0, 2, 5, 8, 12
measure: SANE score
timeFrame: Months 0, 2, 5, 8, 12
measure: Return-to-play
timeFrame: Months 5, 8, 12
measure: Clinical evaluation: reverse pivot shift test
timeFrame: Months 0, 2, 5, 8, 12
measure: Clinical evaluation: anterior drawer test
timeFrame: Months 0, 2, 5, 8, 12
measure: Clinical evaluation: Lachman test
timeFrame: Months 0, 2, 5, 8, 12
measure: Clinical evaluation: thigh circumference 10 cm proximal to the patella
timeFrame: Months 0, 2, 5, 8, 12
measure: Clinical evaluation: thigh circumference 15 cm proximal to the patella
timeFrame: Months 0, 2, 5, 8, 12
measure: Clinical evaluation: knee extension
timeFrame: Months 0, 2, 5, 8, 12
measure: Isokinetic test: knee extensors concentric strength
timeFrame: Months 5 & 8
measure: Isokinetic test: knee flexors concentric strength
timeFrame: Months 5 & 8
measure: Isokinetic test: knee flexors eccentric strength
timeFrame: Months 5 & 8
measure: Rerupture rate
timeFrame: Year 3
Other outcomes:
measure: Demographics: Age
timeFrame: Month 0
measure: Demographics: Sex
timeFrame: Month 0
measure: Demographics: timing between the trauma and the surgery
timeFrame: Month 0
measure: Demographics: active tobacco use
timeFrame: Month 0
measure: Demographics: dyslipidemia
timeFrame: Month 0
measure: Demographics: past surgery of the knee
timeFrame: Month 0
measure: Demographics: Beighton score (joint hypermobility)
timeFrame: Month 0
measure: Medial femorotibial chondropathy
timeFrame: Month 0
measure: Lateral femorotibial chondropathy
timeFrame: Month 0
measure: Femoropatellar chondropathy
timeFrame: Month 0
measure: Internal lateral ligament tear
timeFrame: Month 0
measure: External lateral ligament tear
timeFrame: Month 0
measure: Internal meniscus lesion
timeFrame: Month 0
measure: External meniscus lesion
timeFrame: Month 0
measure: Surgical repair of the anterolateral ligament
timeFrame: Month 0
measure: Anterolateral ligament tear
timeFrame: Month 0
Locations:
city: Neuchâtel
country: Switzerland
facility: Hôpital de la Providence
Study officials:
affiliation: Hôpital de la Providence
name: Adrien Schwitzguébel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nwachukwu BU, Chang B, Voleti PB, Berkanish P, Cohn MR, Altchek DW, Allen AA, Williams RJ Rd. Preoperative Short Form Health Survey Score Is Predictive of Return to Play and Minimal Clinically Important Difference at a Minimum 2-Year Follow-up After Anterior Cruciate Ligament Reconstruction. Am J Sports Med. 2017 Oct;45(12):2784-2790. doi: 10.1177/0363546517714472. Epub 2017 Jul 20.
citation: Sonnery-Cottet B, Saithna A, Cavalier M, Kajetanek C, Temponi EF, Daggett M, Helito CP, Thaunat M. Anterolateral Ligament Reconstruction Is Associated With Significantly Reduced ACL Graft Rupture Rates at a Minimum Follow-up of 2 Years: A Prospective Comparative Study of 502 Patients From the SANTI Study Group. Am J Sports Med. 2017 Jun;45(7):1547-1557. doi: 10.1177/0363546516686057. Epub 2017 Feb 2.