Title
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties
Phase
Phase 2Lead Sponsor
IC-MedTech CorporationStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Edematous Synovitis Foreign Body Reaction OsteolysisIntervention/Treatment
menadiol ...Study Participants
57This 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.
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.
Two capsules taken twice daily with meals
Two capsules taken twice daily with meals
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
| Event Type | Organ System | Event Term | Oral Apatone®B | Placebo |
|---|
Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain
HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score. Scale range HSS total: 100-90 Excellent; 80-89 Very Good; 70-79 Good; 60-69 Fair; below 60 Poor Scale range HSS pain walking: No Pain 15; Mild Pain 10; Moderate Pain 5; Severe Pain 0 (**this is an element of the HSS total) Scale range KSS: 80-100 Excellent; 70-79 Good; 60-69 Fair; below 60 Poor
The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrilinks-D enzyme-linked immunosorbent assay kits from R&D Systems (Minneapolis, MN) and Metra Biosystems (Mountain View, CA), respectively. Lower TGFBeta concentrations represent a better outcome.
The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrlinks-D enzyme-linked immunosorbent assay kits from R&D Systems(minneapolis, MN) and Metra Biosystems (Mountain View, CA) respectively. Lower DPD concentrations represent a better outcome
