Clinical trial NCT02505659: Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture
Official title: Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Rupture
Keywords: Anterior cruciate ligament rupture
Preoperative re-education
Knee functional performance
Anterior cruciate ligament surgery
Single-leg hop for distance test performance
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional performance as assessed by single-leg hop for distance test performance
timeFrame: at 4 months after ACR surgery.
Secondary outcomes:
measure: Ability to return to high level athletics as assessed by single-leg hop for distance test performance
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
measure: Dynamic balance as assessed by star excursion balance test
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
measure: Quadriceps muscular strength as assessed by isokinetic test of quadriceps muscular strength
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
measure: Proprioception as assessed by repositioning knee test
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for:
measure: Knee anterior stability as assessed by KT-1000
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
measure: Subjective knee evaluation as assessed by International Knee Documentation committee 2000 questionnaire
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
measure: Knee symptoms as assessed by Lysholme questionnaire
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
measure: Physical activity level as assessed by Tegner knee scoring
timeFrame: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Aurore CHABAUD
role: PRINCIPAL_INVESTIGATOR
References: