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

Sponsors

Lead Sponsor: IC-MedTech Corporation

Collaborator: Summa Health System
Crystal Clinic Orthopaedic Center LLC

Source 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.

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.

Overall Status Completed
Start Date October 2010
Completion Date December 2015
Primary Completion Date December 2014
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Pain Visual Analog Scale (VAS) 13-weeks
Secondary Outcome
Measure Time Frame
Surrogate Endpoint Markers (SEBs) 13 weeks
TGFBeta Levels Baseline and 13 Weeks
Deoxypyridinoline Levels Baseline and 13 Weeks
Enrollment 57
Condition
Intervention

Intervention Type: Drug

Intervention Name: Placebo

Description: Two capsules taken twice daily with meals

Arm Group Label: Placebo

Intervention Type: Drug

Intervention Name: Apatone®B

Description: Two capsules taken twice daily with meals

Arm Group Label: oral Apatone®B

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

Gender: All

Minimum Age: 50 Years

Maximum Age: 85 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Location
Facility: Summa Health System
Location Countries

United States

Verification Date

October 2017

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: oral Apatone®B

Type: Experimental

Description: An amalgam of Vitamins C & K3

Label: Placebo

Type: Placebo Comparator

Description: Oral capsule of similar appearance and taste without Apatone®B

Acronym Apatone-B
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov