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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 : Completed
First Posted : January 10, 2011
Results First Posted : January 31, 2018
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Summa Health System
Crystal Clinic Orthopaedic Center LLC
Information provided by (Responsible Party):
IC-MedTech Corporation

December 17, 2010
January 10, 2011
July 19, 2017
January 31, 2018
January 31, 2018
October 2010
December 2014   (Final data collection date for primary outcome measure)
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

Surrogate Endpoint Biomarkers [ Time Frame: 13-weeks ]
Biochemical, Functional, and Emotional endpoints
Complete list of historical versions of study NCT01272830 on ClinicalTrials.gov Archive Site
  • Surrogate Endpoint Markers (SEBs) [ Time Frame: 13 weeks ]

    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 [ 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.

  • 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

Not Provided
Not Provided
Not Provided
 
Double-Blinded Clinical Trial Using Apatone®B for Symptomatic Postoperative Total Joint Replacements
A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Edematous
  • Synovitis
  • Foreign Body Reaction
  • Osteolysis
  • Drug: Placebo
    Two capsules taken twice daily with meals
  • Drug: Apatone®B
    Two capsules taken twice daily with meals
  • Experimental: oral Apatone®B
    An amalgam of Vitamins C & K3
    Intervention: Drug: Apatone®B
  • Placebo Comparator: Placebo
    Oral capsule of similar appearance and taste without Apatone®B
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
57
60
December 2015
December 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01272830
Summa-09136
Yes
Not Provided
Plan to Share IPD: No
IC-MedTech Corporation
IC-MedTech Corporation
  • Summa Health System
  • Crystal Clinic Orthopaedic Center LLC
Principal Investigator: Thomas F Bear, MD Crystal Clinic Orthopaedic Center LLC
Study Director: Mark W Kovacik, BS Summa Health System
IC-MedTech Corporation
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP