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

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ClinicalTrials.gov Identifier: NCT01272830
Recruitment Status : Unknown
Verified March 2015 by IC-MedTech Corporation.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2011
Last Update Posted : March 26, 2015
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Edematous Synovitis Foreign Body Reaction Osteolysis Drug: Placebo Drug: Apatone®B Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Study Start Date : October 2010
Primary Completion Date : December 2014
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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


Eligibility Criteria

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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 Posted: January 10, 2011    Key Record Dates
Last Update Posted: March 26, 2015
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