Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)
This study is currently recruiting participants.
Verified July 2012 by Summa Health System
Sponsor:
Summa Health System
Collaborator:
Crystal Clinic Orthopaedic Center LLC
Information provided by:
Summa Health System
ClinicalTrials.gov Identifier:
NCT01272830
First received: December 17, 2010
Last updated: July 19, 2012
Last verified: July 2012
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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 2012 |
| Estimated Primary Completion Date: | October 2012 (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
Contacts
| Contact: Thomas F Bear, MD | 330-929-9136 | tomorthodoc@aol.com |
| Contact: Mark W Kovacik, BS | 330-379-5885 | kovacikm@summahealth.org |
Locations
| United States, Ohio | |
| Summa Health System | Recruiting |
| Akron, Ohio, United States, 44310 | |
| Contact: Mark W Kovacik, BS 330-379-5885 kovacikm@summahealth.org | |
| Contact: Deborah R Neal, BS(MT) 330-379-8176 neald@summahealth.org | |
| Principal Investigator: Thomas F Bear, MD | |
| Sub-Investigator: Ian M Gradisar, MD | |
| Sub-Investigator: James M Jamison, PhD | |
| Sub-Investigator: Richard A Mostardi, PhD | |
| Sub-Investigator: Mark W Kovacik, BS | |
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 F. Bear, M.D., Crystal Clinic Orthopaedic Center LLC |
| ClinicalTrials.gov Identifier: | NCT01272830 History of Changes |
| Other Study ID Numbers: | Summa-09136 |
| Study First Received: | December 17, 2010 |
| Last Updated: | July 19, 2012 |
| 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 June 18, 2013