MedTrace Logo

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

NCT01272830 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2018-01-31

Study results available
· View outcomes & findings →

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.

Conditions

  • Edematous
  • Synovitis
  • Foreign Body Reaction
  • Osteolysis

Interventions

DRUG

Placebo

Two capsules taken twice daily with meals

DRUG

Apatone®B

Two capsules taken twice daily with meals

Sponsors & Collaborators

  • Summa Health System

    collaborator OTHER

  • Crystal Clinic Orthopaedic Center LLC

    collaborator OTHER

  • IC-MedTech Corporation

    lead INDUSTRY

Principal Investigators

  • Thomas F Bear, MD · Crystal Clinic Orthopaedic Center LLC

  • Mark W Kovacik, BS · Summa Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01272830 on ClinicalTrials.gov