Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Crystal Clinic Orthopaedic Center LLC
Information provided by (Responsible Party):
Thomas Bear, Summa Health System Identifier:
First received: December 17, 2010
Last updated: November 20, 2013
Last verified: November 2013

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.

Condition Intervention Phase
Foreign Body Reaction
Drug: Placebo
Drug: Apatone®B
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties

Resource links provided by NLM:

Further study details as provided by Summa Health System:

Primary Outcome Measures:
  • Surrogate Endpoint Biomarkers [ Time Frame: 13-weeks ] [ Designated as safety issue: Yes ]
    Biochemical, Functional, and Emotional endpoints

Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oral Apatone®B
An amalgum of Vitamins C & K3
Drug: Apatone®B
Two capsules taken twice daily with meals
Placebo Comparator: Placebo
Oral capsule of similar appearance and taste without Apatone®B
Drug: Placebo
Two capsules taken twice daily with meals

Detailed 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.


Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01272830

United States, Ohio
Summa Health System
Akron, Ohio, United States, 44310
Sponsors and Collaborators
Summa Health System
Crystal Clinic Orthopaedic Center LLC
Principal Investigator: Thomas F Bear, MD Crystal Clinic Orthopaedic Center LLC
Study Director: Mark W Kovacik, BS Summa Health System
  More Information

No publications provided

Responsible Party: Thomas Bear, Principal Investigator, Summa Health System Identifier: NCT01272830     History of Changes
Other Study ID Numbers: Summa-09136
Study First Received: December 17, 2010
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Summa Health System:
total joint arthroplasty
periprosthetic metallosis

Additional relevant MeSH terms:
Foreign-Body Reaction
Foreign Bodies
Pathologic Processes
Wounds and Injuries processed this record on February 27, 2015