Anterior Cruciate Ligament Rupture, Surgery
Conditions
Keywords
Anterior Cruciate Ligament Rupture, Anterolateral ligament, Ultrasonography
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.
Interventions
PROCEDUREACL repair without anterolateral repair
Surgical repair of the ACL using semitendinous autograft
PROCEDUREACL 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)
Sponsors
Adrien Schwitzguebel
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IKDC score | Month 8 | Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lysholm score | Months 0, 2, 5, 8, 12 | 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) |
| SANE score | Months 0, 2, 5, 8, 12 | The Single Numeric Assessment Evaluation is a subjective percentage of the knee functionality, scaled between 0% and 100% (100% = good function) |
| Return-to-play | Months 5, 8, 12 | Timing when return-to-play to full sports activities is possible |
| Clinical evaluation: reverse pivot shift test | Months 0, 2, 5, 8, 12 | Described as Clunk absent, Clunk present, or Clunk present with shake |
| Clinical evaluation: anterior drawer test | Months 0, 2, 5, 8, 12 | Described as Hard stop, Soft stop, or Soft stop and increased course |
| Clinical evaluation: Lachman test | Months 0, 2, 5, 8, 12 | Described as Hard stop, Soft stop, or Soft stop and increased course |
| IKDC score | Months 0, 2, 5, 12 | Self-reported IKDC (International Knee Documentation Committee Subjective Knee Form) score, scaled between 0 and 100 (100 = good function) |
| Clinical evaluation: thigh circumference 15 cm proximal to the patella | Months 0, 2, 5, 8, 12 | measure in cm |
| Clinical evaluation: knee extension | Months 0, 2, 5, 8, 12 | Measured in °. Negative values associated with bad outcome |
| Isokinetic test: knee extensors concentric strength | Months 5 & 8 | Measured in absolute value and comparative value with controlateral limb |
| Isokinetic test: knee flexors concentric strength | Months 5 & 8 | Measured in absolute value and comparative value with controlateral limb |
| Isokinetic test: knee flexors eccentric strength | Months 5 & 8 | Measured in absolute value and comparative value with controlateral limb |
| Rerupture rate | Year 3 | Patients will be evaluated by phone at 3 years of follow-up. Rerupture of the ACL graft (yes-no) will be recorded. |
| Clinical evaluation: thigh circumference 10 cm proximal to the patella | Months 0, 2, 5, 8, 12 | measure in cm |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographics: dyslipidemia | Month 0 | binary outcome (yes - no) |
| Anterolateral ligament tear | Month 0 | Described as intact, partial tear, full teat or non evaluable on ultrasonography |
| Demographics: Age | Month 0 | Age of the patient (years) |
| Demographics: Sex | Month 0 | Sex of the patient |
| Demographics: timing between the trauma and the surgery | Month 0 | Time in days |
| Demographics: active tobacco use | Month 0 | binary outcome (yes - no) |
| Demographics: past surgery of the knee | Month 0 | binary outcome (yes - no) |
| Demographics: Beighton score (joint hypermobility) | Month 0 | graded from 0 (no joint hypermobility) to 9 (major joint hypermobility) |
| Medial femorotibial chondropathy | Month 0 | Graded from 0 to 4 on arthroscopy |
| Lateral femorotibial chondropathy | Month 0 | Graded from 0 to 4 on arthroscopy |
| Femoropatellar chondropathy | Month 0 | Graded from 0 to 4 on arthroscopy |
| Internal lateral ligament tear | Month 0 | Described as absent, partial, or full on MRI |
| External lateral ligament tear | Month 0 | Described as absent, partial, or full on MRI |
| Internal meniscus lesion | Month 0 | Described as absent, present, not repaired, or present, repaired on arthroscopy |
| External meniscus lesion | Month 0 | Described as absent, present, not repaired, or present, repaired on arthroscopy |
| Surgical repair of the anterolateral ligament | Month 0 | Described as not performed, or performed during surgery |
Countries
Switzerland
Contacts
Primary ContactAdrien Schwitzguébel, MD
Outcome results
None listed