ALL Ultrasound Predicts the Success of ACL Repair?

Surgery Clinical Trial

— ALL_US  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04373408
• Other study ID #: ALL Providence
• Status: Recruiting
• Start date: July 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: September 2021
• Source: Hôpital de la Providence, Switzerland
• Contact: Adrien Schwitzguébel, MD
• Phone: 0797620562
• Email: adrien.schwitzguebel[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries
• Anterior Cruciate Ligament Rupture
• Rupture
• Surgery

Intervention

Procedure:
• ACL repair without anterolateral repair
Surgical repair of the ACL using semitendinous autograft
• 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)

Locations

Country	Name	City	State
Switzerland	Hôpital de la Providence	Neuchâtel

Sponsors (1)

Lead Sponsor	Collaborator
Adrien Schwitzguebel

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics: Age	Age of the patient (years)	Month 0
Other	Demographics: Sex	Sex of the patient	Month 0
Other	Demographics: timing between the trauma and the surgery	Time in days	Month 0
Other	Demographics: active tobacco use	binary outcome (yes - no)	Month 0
Other	Demographics: dyslipidemia	binary outcome (yes - no)	Month 0
Other	Demographics: past surgery of the knee	binary outcome (yes - no)	Month 0
Other	Demographics: Beighton score (joint hypermobility)	graded from 0 (no joint hypermobility) to 9 (major joint hypermobility)	Month 0
Other	Medial femorotibial chondropathy	Graded from 0 to 4 on arthroscopy	Month 0
Other	Lateral femorotibial chondropathy	Graded from 0 to 4 on arthroscopy	Month 0
Other	Femoropatellar chondropathy	Graded from 0 to 4 on arthroscopy	Month 0
Other	Internal lateral ligament tear	Described as "absent", "partial", or "full" on MRI	Month 0
Other	External lateral ligament tear	Described as "absent", "partial", or "full" on MRI	Month 0
Other	Internal meniscus lesion	Described as "absent", "present, not repaired", or "present, repaired" on arthroscopy	Month 0
Other	External meniscus lesion	Described as "absent", "present, not repaired", or "present, repaired" on arthroscopy	Month 0
Other	Surgical repair of the anterolateral ligament	Described as "not performed", or "performed" during surgery	Month 0
Other	Anterolateral ligament tear	Described as "intact", "partial tear", "full teat" or "non evaluable on ultrasonography	Month 0
Primary	IKDC score	Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function)	Month 8
Secondary	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
Secondary	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
Secondary	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
Secondary	Return-to-play	Timing when return-to-play to full sports activities is possible	Months 5, 8, 12
Secondary	Clinical evaluation: reverse pivot shift test	Described as "Clunk absent", "Clunk present", or "Clunk present with shake"	Months 0, 2, 5, 8, 12
Secondary	Clinical evaluation: anterior drawer test	Described as "Hard stop", "Soft stop", or "Soft stop and increased course"	Months 0, 2, 5, 8, 12
Secondary	Clinical evaluation: Lachman test	Described as "Hard stop", "Soft stop", or "Soft stop and increased course"	Months 0, 2, 5, 8, 12
Secondary	Clinical evaluation: thigh circumference 10 cm proximal to the patella	measure in cm	Months 0, 2, 5, 8, 12
Secondary	Clinical evaluation: thigh circumference 15 cm proximal to the patella	measure in cm	Months 0, 2, 5, 8, 12
Secondary	Clinical evaluation: knee extension	Measured in °. Negative values associated with bad outcome	Months 0, 2, 5, 8, 12
Secondary	Isokinetic test: knee extensors concentric strength	Measured in absolute value and comparative value with controlateral limb	Months 5 & 8
Secondary	Isokinetic test: knee flexors concentric strength	Measured in absolute value and comparative value with controlateral limb	Months 5 & 8
Secondary	Isokinetic test: knee flexors eccentric strength	Measured in absolute value and comparative value with controlateral limb	Months 5 & 8
Secondary	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