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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Crystal Clinic Orthopaedic Center LLC
Information provided by (Responsible Party):
Thomas Bear, Summa Health System
ClinicalTrials.gov Identifier:
NCT01272830
First received: December 17, 2010
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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
Edematous
Synovitis
Foreign Body Reaction
Osteolysis
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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272830

Locations
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44310
Sponsors and Collaborators
Summa Health System
Crystal Clinic Orthopaedic Center LLC
Investigators
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
ClinicalTrials.gov 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
synovitis
ALVAL
osteolysis
periprosthetic metallosis

Additional relevant MeSH terms:
Edema
Foreign Bodies
Foreign-Body Reaction
Osteolysis
Synovitis
Signs and Symptoms
Wounds and Injuries
Inflammation
Pathologic Processes
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Joint Diseases

ClinicalTrials.gov processed this record on April 22, 2014