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Trial record 1 of 1 for:    apatone
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Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2015 by IC-MedTech Corporation.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01272830
First Posted: January 10, 2011
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Summa Health System
Crystal Clinic Orthopaedic Center LLC
Information provided by (Responsible Party):
IC-MedTech Corporation
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 IC-MedTech Corporation:

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


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01272830


Locations
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44310
Sponsors and Collaborators
IC-MedTech Corporation
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

Responsible Party: IC-MedTech Corporation
ClinicalTrials.gov Identifier: NCT01272830     History of Changes
Other Study ID Numbers: Summa-09136
First Submitted: December 17, 2010
First Posted: January 10, 2011
Last Update Posted: October 12, 2017
Last Verified: March 2015

Keywords provided by IC-MedTech Corporation:
total joint arthroplasty
synovitis
ALVAL
osteolysis
periprosthetic metallosis

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