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

Anterior Cruciate Ligament Rupture Clinical Trial

— PRELIG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02505659
• Other study ID #: CHU-0240
• Secondary ID: 2014-A01845
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2015
• Last updated: July 28, 2016
• Start date: February 2015
• Est. completion date: January 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Rupture
• Rupture

Intervention

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

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional performance as assessed by single-leg hop for distance test performance		at 4 months after ACR surgery.	Yes
Secondary	Ability to return to high level athletics as assessed by single-leg hop for distance test performance	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:	Yes
Secondary	Dynamic balance as assessed by star excursion balance test	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:	Yes
Secondary	Quadriceps muscular strength as assessed by isokinetic test of quadriceps muscular strength	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:	Yes
Secondary	Proprioception as assessed by repositioning knee test	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:	Yes
Secondary	Knee anterior stability as assessed by KT-1000	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	Yes
Secondary	Subjective knee evaluation as assessed by International Knee Documentation committee 2000 questionnaire	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	Yes
Secondary	Knee symptoms as assessed by Lysholme questionnaire	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	Yes
Secondary	Physical activity level as assessed by Tegner knee scoring	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	Yes