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