Anterior Cruciate Ligament RupturePRELIGNCT02505659
Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture
A study testing Preoperative re-education in people with Anterior Cruciate Ligament Rupture, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Rupture
- What is being tested?
- Preoperative re-education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Aurore CHABAUD
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Rupture
- Being tested
- Preoperative re-education
- Keywords
- Anterior cruciate ligament rupture, Preoperative re-education, Knee functional performance, Anterior cruciate ligament surgery, Single-leg hop for distance test performance
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative re-educationBehavioural
Preoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Preoperative re-education |
| CONTRL GROUP | No intervention | a control group (without preoperative reeducation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance as assessed by single-leg hop for distance test performance
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: 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
Assessment for both control and experimental group : inclusion (V0) preoperative visit (V1), 4-month follow-up (V4M) and 7-month follow-up (V7M)
Measured: at 4-month follow-up and 7-month follow-up compared to the initial visit and control group for
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament RuptureStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurore CHABAUD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505659
- Sponsor's protocol ID
- CHU-0240
- Other IDs
- 2014-A01845
- Acronym
- PRELIG
- Status last verified
- Jul 2016
- First submitted
- 26 Jun 2015
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Preoperative Re-education on Patients With an Anterior Cruciate Ligament Rupture: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02505659
- Acronym / sponsor ID
- PRELIG / CHU-0240
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EXPERIMENTAL GROUP | Experimental | Behavioral: Preoperative re-educationSessions 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. |
| CONTRL GROUP | No intervention | –a control group (without preoperative reeducation) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative re-educationPreoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks | Behavioural | EXPERIMENTAL GROUP |
Primary outcome
Functional performance as assessed by single-leg hop for distance test performance
Time frame: at 4 months after ACR surgery.
8 secondary outcomes
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:
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:
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:
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:
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aurore CHABAUD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative re-education in people with Anterior Cruciate Ligament Rupture, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional performance as assessed by single-leg hop for distance test performance (time frame: at 4 months after ACR surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.