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Clinical Trials/NCT02505659
NCT02505659
Unknown
Not Applicable

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

University Hospital, Clermont-Ferrand1 site in 1 country80 target enrollmentFebruary 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anterior Cruciate Ligament Rupture
Sponsor
University Hospital, Clermont-Ferrand
Enrollment
80
Locations
1
Primary Endpoint
Functional performance as assessed by single-leg hop for distance test performance
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2015
End Date
January 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Clermont-Ferrand
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Functional performance as assessed by single-leg hop for distance test performance

Time Frame: at 4 months after ACR surgery.

Secondary Outcomes

  • 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)
  • 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:)
  • 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:)
  • 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:)
  • 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:)
  • 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)
  • 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)
  • 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)

Study Sites (1)

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