- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01272830
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)
A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Ohio
-
Akron, Ohio, United States, 44310
- Summa Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Postoperative Total joint replacement with osteoarthritis as the underlying pathology
- Proven non-infected symptomatic Total Joint Arthroplasty (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 Toradol); 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 Recommended Daily Allowance (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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: oral Apatone®B
An amalgam of Vitamins C & K3
|
Two capsules taken twice daily with meals
|
PLACEBO_COMPARATOR: Placebo
Oral capsule of similar appearance and taste without Apatone®B
|
Two capsules taken twice daily with meals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Visual Analog Scale (VAS)
Time Frame: 13-weeks
|
Pain Visual Analog Scale (VAS) Scale range (0-100) A higher VAS score indicate worse knee pain |
13-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Surrogate Endpoint Markers (SEBs)
Time Frame: 13 weeks
|
HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.
|
13 weeks
|
TGFBeta Levels
Time Frame: Baseline and 13 Weeks
|
The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrilinks-D enzyme-linked immunosorbent assay kits from R&D Systems (Minneapolis, MN) and Metra Biosystems (Mountain View, CA), respectively. Lower TGFBeta concentrations represent a better outcome. |
Baseline and 13 Weeks
|
Deoxypyridinoline Levels
Time Frame: Baseline and 13 Weeks
|
The final synovial aspirates obtained from the symptomatic knee of each subject were analyzed using Quantikine and Pyrlinks-D enzyme-linked immunosorbent assay kits from R&D Systems(minneapolis, MN) and Metra Biosystems (Mountain View, CA) respectively. Lower DPD concentrations represent a better outcome |
Baseline and 13 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Thomas F Bear, MD, Crystal Clinic Orthopaedic Center LLC
- Study Director: Mark W Kovacik, BS, Summa Health System
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Summa-09136
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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