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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties

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 Summary: 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.
Sponsor: IC-MedTech Corporation

Current Primary Outcome: Surrogate Endpoint Biomarkers [ Time Frame: 13-weeks ]

Biochemical, Functional, and Emotional endpoints


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: IC-MedTech Corporation

Dates:
Date Received: December 17, 2010
Date Started: October 2010
Date Completion: December 2015
Last Updated: March 25, 2015
Last Verified: March 2015