Evaluation of Efficacy and Tolerance of a Food Supplement (MYOSTIM®) in Postoperative Revalidation of Patients After Reconstructive Surgery of Anterior Cruciate Ligament
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Assess the efficacy of MYOSTIM® on the global judgment of the patient
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Two parallel-groups either the MYOSTIM® or a PLACEBO in a double blinded manner.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Assess the efficacy of MYOSTIM® on the global judgment of the patient
时间窗: Change from Baseline at 2 and14 weeks post ACL surgery
Evaluation of global judgment of the patient by one visual analogue scale (VAS)
Assess the efficacy of MYOSTIM® on physical performance recovery
时间窗: 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
时间窗: 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
时间窗: Change from Baseline at 2 and14 weeks post ACL surgery
Evaluation of pain of the patient by one visual analogue scale (VAS)
Assessment of the tolerance of the patient with the MYOSTIM®
时间窗: 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®
时间窗: At 14 weeks post ACL surgery
Evaluation according the number of remaining bars
Assessment of the satisfaction of the patient with the MYOSTIM®
时间窗: At 14 weeks post ACL surgery
Evaluation according the satisfaction scale for the product
Assess the efficacy of MYOSTIM® on the muscular mass recovery
时间窗: Change from Baseline at 14 weeks post ACL surgery
Evaluation by Magnetic Resonance Imaging (MRI)
Assess the efficacy of MYOSTIM® on the muscular strength recovery
时间窗: Change from Baseline at 14 weeks post ACL surgery
Evaluation by isokinetic test performed (extension/flexion of the quadriceps)
次要结局
未报告次要终点