A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Pain Visual Analog Scale (VAS)
研究概览
简要总结
This research study is being conducted to determine if taking oral (by mouth in pill form) Apatone®B (a combination of Vitamins C and K3) will reduce chronic joint discomfort and improve function of non-infected symptomatic postoperative total joint replacements.
详细描述
To perform a prospective, randomized, double-blind clinical trial to determine if oral Apatone®B, an amalgam of vitamins C and K3, has a therapeutic efficacy beyond the conservative care customarily used to reduce inflammatory synovitis and to increase the functional capacity of proven non-infected symptomatic postoperative total joint replacements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Postoperative Total joint replacement with osteoarthritis as the underlying pathology
- •Proven non-infected symptomatic Total Joint Arthroplasty (TJA) (joint implanted for >12 months post-op)
- •Age (50 to 85 years of age); based on a 10% trim of the age distribution for Summa Health System TJAs (7/1/08-6/30/2009).
排除标准
- •An infection of any kind (prior to, or during the study)
- •Rheumatoid arthritis as the underlying pathology
- •Cortisone injection received <6 months prior to study enrollment
- •Insulin dependent diabetes
- •Diagnosed immunodeficiency
- •On dialysis or have poor kidney function
- •Anti-coagulant medication (e.g., Coumadin or >100mg of Aspirin daily)
- •Anti-seizure medication (e.g., Dilantin)
- •Steroidal medication (e.g., Prednisone, Advair or Symbicort)
- •NSAIDS (e.g., Celebrex or Toradol); a 14-day washout period will be allowed
- •bisphosphonates (e.g., Fosamax, Actonel, Aredia, Didronel, Boniva or Reclast)
- •hormonal therapy (e.g., Estrogen, Progesterone or Testosterone)
- •Cancer (active or in remission)
- •Planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the Recommended Daily Allowance (RDA) for individual vitamins if used alone; a 72 hour wash out period will be allowed
- •A glucose-6-phosphate dehydrogenase (G6PD) deficiency
- •Pregnant or lactating; females who are in their reproductive years must have a negative serum pregnancy
- •Lactose intolerant
- •Citric acid intolerant
研究组 & 干预措施
oral Apatone®B
An amalgam of Vitamins C & K3
干预措施: Apatone®B (Drug)
Placebo
Oral capsule of similar appearance and taste without Apatone®B
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Visual Analog Scale (VAS)
时间窗: 13-weeks
Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain
次要结局
- Deoxypyridinoline Levels(Baseline and 13 Weeks)
- TGFBeta Levels(Baseline and 13 Weeks)
- Surrogate Endpoint Markers (SEBs)(13 weeks)