Overview

This trial is active, not recruiting.

Conditions edematous, synovitis, foreign body reaction, osteolysis
Treatments placebo, apatone®b
Phase phase 2
Sponsor IC-MedTech Corporation
Collaborator Summa Health System
Start date October 2010
End date December 2014
Trial size 60 participants
Trial identifier NCT01272830, Summa-09136

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
An amalgum of Vitamins C & K3
apatone®b
Two capsules taken twice daily with meals
(Placebo Comparator)
Oral capsule of similar appearance and taste without Apatone®B
placebo
Two capsules taken twice daily with meals

Primary Outcomes

Measure
Surrogate Endpoint Biomarkers
time frame: 13-weeks

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by IC-MedTech Corporation.