At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 57 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective Double-Blinded Clinical Trial Using Apatone®B for Care and Treatment of Proven Non-Infected Symptomatic Postoperative Total Joint Arthroplasties
In Brief
A Phase 2 clinical trial evaluating Placebo and Apatone®B for Edematous and 3 related conditions. Completed, enrolled 57 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEdematous, Synovitis, Foreign Body Reaction, Osteolysis
CountriesUnited States
CollaboratorsSumma Health System, Crystal Clinic Orthopaedic Center LLC
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2010
First PostedJan 2011
Primary CompletionDec 2014
Study CompletionDec 2015
TodayJul 2026
First PostedJan 10, 2011
Enrollment StartOct 1, 2010
Primary CompletionDec 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 15.5 years ago
Interventions
Placebodrug
Two capsules taken twice daily with meals
Apatone®Bdrug
Two capsules taken twice daily with meals