ALL Ultrasound Predicts the Success of ACL Repair? (ALL_US)

Does Anterolateral Ligament Ultrasound Influences the Return-to-play After Anterior Cruciate Ligament Rupture? Survival Analysis

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.

Study Overview

• Status: Recruiting
• Conditions: Anterior Cruciate Ligament Rupture; Surgery
• Intervention / Treatment: Procedure: ACL repair without anterolateral repair; Procedure: ACL repair with anterolateral repair

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Adrien Schwitzguébel, MD; Phone Number: 0797620562; Email: adrien.schwitzguebel@gmail.com

Study Locations

• Switzerland
  • Neuchâtel, Switzerland, 2000
    • Recruiting
    • Hôpital de La Providence
    • Contact: Adrien Schwitzguébel, MD; Phone Number: 004132 720 32 75; Email: adrien.schwitzguebel@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

ACL rupture

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ACL rupture without indication for ALL surgery; Patients with an ACL rupture undergoing surgical repair of the ACL only	Procedure: ACL repair without anterolateral repair; Surgical repair of the ACL using semitendinous autograft
ACL rupture with indication for ALL surgery; Patients with an ACL rupture undergoing surgical repair of the ACL and the ALL	Procedure: ACL repair with anterolateral repair; Surgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC score	Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function)	Month 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IKDC score	Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function)	Months 0, 2, 5, 12
Lysholm score	The Lysholm score is a 100-point scoring system for examining a patient's knee-specific symptoms including mechanical locking, instability, pain, swelling, stair climbing, and squatting, scaled between 0 and 100 (100 = good function)	Months 0, 2, 5, 8, 12
SANE score	The Single Numeric Assessment Evaluation is a subjective percentage of the knee functionality, scaled between 0% and 100% (100% = good function)	Months 0, 2, 5, 8, 12
Return-to-play	Timing when return-to-play to full sports activities is possible	Months 5, 8, 12
Clinical evaluation: reverse pivot shift test	Described as "Clunk absent", "Clunk present", or "Clunk present with shake"	Months 0, 2, 5, 8, 12
Clinical evaluation: anterior drawer test	Described as "Hard stop", "Soft stop", or "Soft stop and increased course"	Months 0, 2, 5, 8, 12
Clinical evaluation: Lachman test	Described as "Hard stop", "Soft stop", or "Soft stop and increased course"	Months 0, 2, 5, 8, 12
Clinical evaluation: thigh circumference 10 cm proximal to the patella	measure in cm	Months 0, 2, 5, 8, 12
Clinical evaluation: thigh circumference 15 cm proximal to the patella	measure in cm	Months 0, 2, 5, 8, 12
Clinical evaluation: knee extension	Measured in °. Negative values associated with bad outcome	Months 0, 2, 5, 8, 12
Isokinetic test: knee extensors concentric strength	Measured in absolute value and comparative value with controlateral limb	Months 5 & 8
Isokinetic test: knee flexors concentric strength	Measured in absolute value and comparative value with controlateral limb	Months 5 & 8
Isokinetic test: knee flexors eccentric strength	Measured in absolute value and comparative value with controlateral limb	Months 5 & 8
Rerupture rate	Patients will be evaluated by phone at 3 years of follow-up. Rerupture of the ACL graft (yes-no) will be recorded.	Year 3

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics: Age	Age of the patient (years)	Month 0
Demographics: Sex	Sex of the patient	Month 0
Demographics: timing between the trauma and the surgery	Time in days	Month 0
Demographics: active tobacco use	binary outcome (yes - no)	Month 0
Demographics: dyslipidemia	binary outcome (yes - no)	Month 0
Demographics: past surgery of the knee	binary outcome (yes - no)	Month 0
Demographics: Beighton score (joint hypermobility)	graded from 0 (no joint hypermobility) to 9 (major joint hypermobility)	Month 0
Medial femorotibial chondropathy	Graded from 0 to 4 on arthroscopy	Month 0
Lateral femorotibial chondropathy	Graded from 0 to 4 on arthroscopy	Month 0
Femoropatellar chondropathy	Graded from 0 to 4 on arthroscopy	Month 0
Internal lateral ligament tear	Described as "absent", "partial", or "full" on MRI	Month 0
External lateral ligament tear	Described as "absent", "partial", or "full" on MRI	Month 0
Internal meniscus lesion	Described as "absent", "present, not repaired", or "present, repaired" on arthroscopy	Month 0
External meniscus lesion	Described as "absent", "present, not repaired", or "present, repaired" on arthroscopy	Month 0
Surgical repair of the anterolateral ligament	Described as "not performed", or "performed" during surgery	Month 0
Anterolateral ligament tear	Described as "intact", "partial tear", "full teat" or "non evaluable on ultrasonography	Month 0

Collaborators and Investigators

• Sponsor: Adrien Schwitzguebel
• Investigators: Principal Investigator: Adrien Schwitzguébel, MD, Hôpital de La Providence

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): September 23, 2021
• Last Update Submitted That Met QC Criteria: September 17, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Anterior Cruciate Ligament Rupture; Ultrasonography; Anterolateral ligament
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Rupture; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: ALL Providence

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No