Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
This trial is active, not recruiting.
|Conditions||edematous, synovitis, foreign body reaction, osteolysis|
|Collaborator||Summa Health System|
|Start date||October 2010|
|End date||December 2014|
|Trial size||60 participants|
|Trial identifier||NCT01272830, Summa-09136|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator, outcomes assessor)|
An amalgum of Vitamins C & K3
Oral capsule of similar appearance and taste without Apatone®B
Surrogate Endpoint Biomarkers
time frame: 13-weeks
Male or female participants from 50 years up to 85 years old.
Inclusion Criteria: - Postoperative Total joint replacement with osteoarthritis as the underlying pathology - Proven non-infected symptomatic 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 Toadol); 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 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
|Official title||A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties|
|Principal investigator||Thomas F Bear, MD|
|Description||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.|
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