Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture

Study Overview
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Brief Summary
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Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning. Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations. The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR. Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery. Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.

Detailed Description
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Anterior cruciate ligament (ACR) rupture is a common lesion of sportsmen that leads to functional deficits which are difficult to overcome. To prevent from an unfavorable evolution, patients can either get a non-surgical treatment or an ACR surgery, which is very common. Knee functional performance level could impact on the postoperative outcome and it's of common knowledge that early re-education after an ACR rupture improves knee functioning. Patients with an ACR rupture enrolled in this study will be randomized either in an experimental group (with preoperative reeducation) or in a control group (without preoperative reeducation). Both groups will then have post-operative re-education (40 sessions) based on HAS recommendations. The main aim of this study is to assess the impact of preoperative re-education on knee functional performance 4 month after surgical reconstruction of an ACR. Secondary aims are to determine the impact of the 4-week preoperative re-education on knee functional performance after an ACR rupture, before surgery and 7 months after surgery. Functional performance, muscular strength, proprioception and anterior knee laxity will be measured at inclusion (V0), 4-5 days before surgery (V1), 4 month (V4M) and 7 months (V7M) after surgery. Lysholme-Tegner scoring and IKDC2000 questionnaire will be added to the previous assessments.

Official Title
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Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial

Conditions
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Anterior Cruciate Ligament Rupture

Intervention / Treatment
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* Behavioral: Preoperative re-education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 18 and 45 years old Tegner physical activity level between 3 and 9 Primary and unilateral rupture of anterior cruciate ligament, confirmed by MRI patient available to carry out the preoperative re-education program Exclusion Criteria: Complex lesion that would impede on preoperative re-education (posterior cruciate ligament, meniscal or chondral symptomatic lesion, fracture)/ Neurologic or cardiorespiratory pathology contra-indicating preoperative re-education Previous surgical treatment of the lower limbs or of the lumbar spine Neuropathic or algodystrophic pain on the lower limbs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERIMENTAL GROUP<br>Sessions are aiming to neuromuscular and functional training. Each session starts with trunk muscle activation. Patients will then have to realize a neuromuscular training on Huber Motion Lab® followed by multiple exercises targeting functional stability and neuromuscular control. From the 4th session, a jump sequence will be added to the previous exercices. Exercises used in this protocol are based upon successful exercises of protocols already performed on patients with anterior cruciate ligament rupture. | Behavioral: Preoperative re-education<br>* Preoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks<br>|
| No Intervention: CONTRL GROUP<br>a control group (without preoperative reeducation) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional performance as assessed by single-leg hop for distance test performance |  | at 4 months after ACR surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to return to high level athletics as assessed by single-leg hop for distance test performance | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for: | 
| Dynamic balance as assessed by star excursion balance test | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for: | 
| Quadriceps muscular strength as assessed by isokinetic test of quadriceps muscular strength | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for: | 
| Proprioception as assessed by repositioning knee test | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for: | 
| Knee anterior stability as assessed by KT-1000 | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for | 
| Subjective knee evaluation as assessed by International Knee Documentation committee 2000 questionnaire | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for | 
| Knee symptoms as assessed by Lysholme questionnaire | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for | 
| Physical activity level as assessed by Tegner knee scoring | Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M) | at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior cruciate ligament rupture, Preoperative re-education, Knee functional performance, Anterior cruciate ligament surgery, Single-leg hop for distance test performance