tolerance, efficacy, revalidation, myostim

Conditions: Anterior Cruciate Ligament Rupture

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 supplement (myostim®) has been developped and is supplied as food bars and composed of pomegranate, leucine, creatine, proteins and d vitamin. the aim of this exploratory study is to assess the efficacy and tolerance of myostim® on muscle performance after acl reconstructive surgery and in postoperative revalidation phase.


Eligibility criteria:
inclusion criteria: * 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 criteria: 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

Keywords: food supplement revalidation after surgery