Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (NCT01272830) | Clinical Trial Compass
CompletedPhase 2
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
United States57 participantsStarted 2010-10
Plain-language 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.
Who can participate
Age range50 Years ā 85 Years
SexALL
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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