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

July 28, 2016 updated by: University Hospital, Clermont-Ferrand

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • CHU Clermont-Ferrand
        • Principal Investigator:
          • Aurore CHABAUD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EXPERIMENTAL GROUP
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
Preoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks
No Intervention: CONTRL GROUP
a control group (without preoperative reeducation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional performance as assessed by single-leg hop for distance test performance
Time Frame: at 4 months after ACR surgery.
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Aurore CHABAUD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Anticipated)

September 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (Estimate)

July 22, 2015

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0240
  • 2014-A01845 (Registry Identifier: 2014-A01845-42)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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