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

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: IC-MedTech Corporation
• Collaborators: Crystal Clinic Orthopaedic Center LLC; Summa Health System

Criteria

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