Anterior Cruciate Ligament Rupture
Conditions
Keywords
food supplement, revalidation after surgery
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 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.
Interventions
DIETARY_SUPPLEMENTMYOSTIM®
Food supplement n° NCT 2485/8 (Red fruits flavor bar) and NCT 2485/7 (Black chocolate flavor bar) delivered by the Federal Public Service, Health, Food chain safety and environment.
DIETARY_SUPPLEMENTPLACEBO
Bars with no active ingredient and the same flavor (chocolate and red fruits).
Sponsors
Artialis
Alternativa International S.A
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Two parallel-groups either the MYOSTIM® or a PLACEBO in a double blinded manner.
Intervention model description
Double blind, exploratory study, monocentric, with a group of control patient with placebo. Two parallel-groups receiving during 12 weeks either the MYOSTIM® or a PLACEBO in a double blinded manner.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the efficacy of MYOSTIM® on the muscular strength recovery | Change from Baseline at 14 weeks post ACL surgery | Evaluation by isokinetic test performed (extension/flexion of the quadriceps) |
| Assess the efficacy of MYOSTIM® on the muscular mass recovery | Change from Baseline at 14 weeks post ACL surgery | Evaluation by Magnetic Resonance Imaging (MRI) |
| Assess the efficacy of MYOSTIM® on physical performance recovery | Change from Baseline at 14 weeks post ACL surgery | Evaluation with one self-administrated knee evaluation questionnaire from the International Knee Documentation Committee |
| Assess the effect of MYOSTIM® on blood biomarker | Change from Baseline at 2 and14 weeks post ACL surgery | Evaluation of blood concentration of biomarker (Myostatin (muscular atrophy), Myeloperoxidase (chronic joint inflammation), Coll2-1 and Coll2-1NO2 (Cartilage inflammation and degradation), IL6 (muscular atrophy and inflammation), MMP3 and NT-CAF (cartilage and neuro-muscular junction), TNFa (inflammation)) |
| Assess the efficacy of MYOSTIM® on the pain of the patient | Change from Baseline at 2 and14 weeks post ACL surgery | Evaluation of pain of the patient by one visual analogue scale (VAS) |
| Assess the efficacy of MYOSTIM® on the global judgment of the patient | Change from Baseline at 2 and14 weeks post ACL surgery | Evaluation of global judgment of the patient by one visual analogue scale (VAS) |
| Assessment of the tolerance of the patient with the MYOSTIM® | At 14 weeks post ACL surgery | Evaluation according the number of Adverse Events (AE), remaining bars and satisfaction scale for the product |
| Assessment of the compliance of the patient with the MYOSTIM® | At 14 weeks post ACL surgery | Evaluation according the number of remaining bars |
| Assessment of the satisfaction of the patient with the MYOSTIM® | At 14 weeks post ACL surgery | Evaluation according the satisfaction scale for the product |
Countries
Belgium
Outcome results
None listed