Back to resultsDouble-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements (Apatone-B)
Primary Purpose
Edematous, Synovitis, Foreign Body Reaction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Apatone®B
Sponsored by
About this trial
This is an interventional treatment trial for Edematous focused on measuring total joint arthroplasty, synovitis, ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion), osteolysis, periprosthetic metallosis
Eligibility Criteria
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
Sites / Locations
- Summa Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
oral Apatone®B
Placebo
Arm Description
An amalgam of Vitamins C & K3
Oral capsule of similar appearance and taste without Apatone®B
Outcomes
Primary Outcome Measures
Pain Visual Analog Scale (VAS)
Pain Visual Analog Scale (VAS)
Scale range (0-100) A higher VAS score indicate worse knee pain
Secondary Outcome Measures
Surrogate Endpoint Markers (SEBs)
HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.
Scale range HSS total: 100-90 Excellent; 80-89 Very Good; 70-79 Good; 60-69 Fair; below 60 Poor
Scale range HSS pain walking: No Pain 15; Mild Pain 10; Moderate Pain 5; Severe Pain 0 (**this is an element of the HSS total)
Scale range KSS: 80-100 Excellent; 70-79 Good; 60-69 Fair; below 60 Poor
TGFBeta Levels
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.
Deoxypyridinoline Levels
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
Full Information
NCT ID
NCT01272830
First Posted
December 17, 2010
Last Updated
January 29, 2018
Sponsor
IC-MedTech Corporation
Collaborators
Summa Health System, Crystal Clinic Orthopaedic Center LLC
1. Study Identification
Unique Protocol Identification Number
NCT01272830
Brief Title
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
Acronym
Apatone-B
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 Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IC-MedTech Corporation
Collaborators
Summa Health System, Crystal Clinic Orthopaedic Center LLC
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edematous, Synovitis, Foreign Body Reaction, Osteolysis
Keywords
total joint arthroplasty, synovitis, ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion), osteolysis, periprosthetic metallosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oral Apatone®B
Arm Type
Experimental
Arm Description
An amalgam of Vitamins C & K3
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral capsule of similar appearance and taste without Apatone®B
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two capsules taken twice daily with meals
Intervention Type
Drug
Intervention Name(s)
Apatone®B
Intervention Description
Two capsules taken twice daily with meals
Primary Outcome Measure Information:
Title
Pain Visual Analog Scale (VAS)
Description
Pain Visual Analog Scale (VAS)
Scale range (0-100) A higher VAS score indicate worse knee pain
Time Frame
13-weeks
Secondary Outcome Measure Information:
Title
Surrogate Endpoint Markers (SEBs)
Description
HSS = Hospital for Special Surgery Knee Score , KSS = Knee Society Knee Score.
Scale range HSS total: 100-90 Excellent; 80-89 Very Good; 70-79 Good; 60-69 Fair; below 60 Poor
Scale range HSS pain walking: No Pain 15; Mild Pain 10; Moderate Pain 5; Severe Pain 0 (**this is an element of the HSS total)
Scale range KSS: 80-100 Excellent; 70-79 Good; 60-69 Fair; below 60 Poor
Time Frame
13 weeks
Title
TGFBeta Levels
Description
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.
Time Frame
Baseline and 13 Weeks
Title
Deoxypyridinoline Levels
Description
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
Time Frame
Baseline and 13 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F Bear, MD
Organizational Affiliation
Crystal Clinic Orthopaedic Center LLC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark W Kovacik, BS
Organizational Affiliation
Summa Health System
Official's Role
Study Director
Facility Information:
Facility Name
Summa Health System
City
Akron
State/Province
Ohio
ZIP/Postal Code
44310
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
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