ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 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
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: oral Apatone®B
An amalgam 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



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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

  2. 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.


  3. 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




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 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

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

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
Results First Posted: January 31, 2018
Last Update Posted: January 31, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by IC-MedTech Corporation:
total joint arthroplasty
synovitis
ALVAL (Aseptic Lymphocyte-Dominant Vasculitis-Associated Lesion)
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