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

NCT02505659 | Unknown

• 2 other identifiers: CHU-02402014-A01845
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

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

  at 4 months after ACR surgery.

Secondary Outcomes (8)

• 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:

• 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:

• 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

Study Arms (2)

EXPERIMENTAL GROUP

EXPERIMENTAL

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

CONTRL GROUP

NO INTERVENTION

a control group (without preoperative reeducation)

Interventions

Preoperative re-education BEHAVIORAL

Preoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks

EXPERIMENTAL GROUP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Officials

• Aurore CHABAUD

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 22, 2015
• Study Start: February 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2017
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

FR (1)