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

Not Applicable

• Conditions: Anterior Cruciate Ligament Rupture

• Registration Number: NCT02505659
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-21
• Study First Posted: 2015-07-22
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-28
• Last Update Posted: 2016-07-29
• Primary Completion: 2016-09
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional performance as assessed by single-leg hop for distance test performance	at 4 months after ACR surgery.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France