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

Completed · Phase 2 · Has a placebo group

Conditions studied: Edematous, Synovitis, Foreign Body Reaction, Osteolysis

In brief

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.

Key facts

Study ID

NCT01272830

Run by

IC-MedTech Corporation

People needed

57

Starts

2010-10-01

Expected to finish

2015-12-01

Last updated by the study team

2018-01-31

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Summa Health System — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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