Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)

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.

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.

• Edematous
• Synovitis
• Foreign Body Reaction
• Osteolysis

• Drug: Placebo
  Two capsules taken twice daily with meals
• Drug: Apatone®B
  Two capsules taken twice daily with meals

• Experimental: oral Apatone®B
  An amalgum of Vitamins C & K3
  Intervention: Drug: Apatone®B
• Placebo Comparator: Placebo
  Oral capsule of similar appearance and taste without Apatone®B
  Intervention: Drug: Placebo

Inclusion Criteria:

• Postoperative Total joint replacement with osteoarthritis as the underlying pathology
• Proven non-infected symptomatic 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).

Exclusion Criteria:

• 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 Toadol); 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 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