NCT01272830

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: IC-MedTech Corporation · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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.

Conditions

• Edematous
• Synovitis
• Foreign Body Reaction
• Osteolysis

Interventions

Type	Name	Description
DRUG	Placebo	Two capsules taken twice daily with meals
DRUG	Apatone®B	Two capsules taken twice daily with meals

Timeline

• Start date: 2010-10-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2011-01-10
• Last updated: 2018-01-31
• Results posted: 2018-01-31

Locations

1 site across 1 country: United States