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 ]
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