Double-Blinded Clinical Trial Using Apatone®B for 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.

Inclusion criteria

• 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).

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 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