Phase 2
N=51
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
Edematous · Synovitis · Foreign Body Reaction · Osteolysis
Bottom Line
View on ClinicalTrials.gov: NCT01272830 ↗Enrolled (actual)
51
Serious AEs
2.6%
Results posted
Jan 2018
Primary outcome: Primary: Pain Visual Analog Scale (VAS) — 57; 46.8; 39.7; 39.1 units on a scale — p=0.0063
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); Apatone®B (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- IC-MedTech Corporation
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Visual Analog Scale (VAS) |
57; 46.8; 39.7; 39.1 | 0.0063 sig |
| SECONDARY Surrogate Endpoint Markers (SEBs) |
5.9; 6.9; 9.1; 7.9; 69.6; 71.9 | 0.0226 sig |
| SECONDARY TGFBeta Levels |
3197.4; 2089.2; 2572.2; 1572.2 | 0.0083 sig |
| SECONDARY Deoxypyridinoline Levels |
8.0; 5.9; 6.4; 6.1 | 0.01 sig |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT01272830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.