Status:
COMPLETED
Tolerance, Efficacy, revAlidation, Myostim
Lead Sponsor:
Alternativa International S.A
Collaborating Sponsors:
Artialis
Conditions:
Anterior Cruciate Ligament Rupture
Eligibility:
All Genders
18-40 years
Phase:
NA
Brief Summary
Evaluation of efficacy and tolerance of a food supplement (MYOSTIM®) versus a placebo in postoperative revalidation of patients after reconstructive surgery of anterior cruciate ligament. The food su...
Eligibility Criteria
Inclusion
- Male between the age of 18 and 40
- BMI (Body Mass Index) ≤ 27
- Candidates for ACL reconstruction surgery of DIDT (Droit Interne et du Demi Tendineux) type
- Able to follow the instruction of the study, to go to the postoperative visits to the investigator, to go to the isokinetic and to the MRI visits
- Having signed an informed consent
Exclusion
- Related to the pathology:
- Patient who have undergone previous ACL reconstruction surgery on the same knee
- Patient who have participated to a therapeutic clinical study 3 months before inclusion
- Patient who plan to follow a workout or a revalidation program after surgery different from classical physiotherapy prescribed by the orthopedic surgeon
- Contralateral limb suffered from trauma, surgery, fracture, tear, tendinopathy, sepsis or immobilization for more than 3 weeks during the last 5 years
- Related to treatment:
- Patient who have eaten doping substances or food supplement building mass and muscle strength during 3 months before inclusion excepted for creatine and beta-alanine for which the washout period is of 6 month before inclusion
- Patient who were treated with antibiotics in the month preceding the inclusion
- Patient treated with pharmacologic agents like statins, immunosuppressors or anti-malaria
- Patient taking androgens (steroids…)
- Patient under treatments which may interfere with the neuromuscular system
- Patient who were treated with analgesic or non-steroidal anti-inflammatory drugs (NSAIDS) 24 hours before inclusion visit
- Related to associated diseases:
- Patient with associated uncontrolled severe disease: severe liver or kidney disease, severe and uncontrolled cardiovascular disease, HIV, B or C hepatitis, tumor
- Patient with thromboembolism disorders
- Patient with inflammatory bowel disease
- Anorexic patient
- Diabetic patient
- Patient with traumatic, neurologic or rheumatic history of the lower limbs
- Related to patient:
- Allergy or contraindication to soy, milk, gluten, nuts or wheat
- Forecasting a high protein diet during the study
- Under guardianship or judicial protection
- Related to MRI counter-indication:
- Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
- Patient with a ferromagnetic splinter in the body, or having wire sutures
- Serious mobility problem (Parkinson, tremors)
- Claustrophobia
- Related to impedancemeter test:
- • Patient with a metal plate at the right ankle
Key Trial Info
Start Date :
March 23 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2017
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04684771
Start Date
March 23 2015
End Date
December 31 2017
Last Update
December 28 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Bois de l'Abbaye et de Hesbaye
Seraing, Liège, Belgium, 4100
2
CHU de Liège
Liège, Belgium, 4000