At a glance
ClinicalIndex Comparison RecordN/ACompleted· 172 enrolled
Drug / intervention
COC 36mmdevice
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.
36mm CERAMAX® Ceramic Hip System PMA PAS STUDY: Short to Mid-Term Follow-up , New Study Subjects (Ceramic Hip System, Subjects Receive CERAMAX 36mm Ceramic Acetabular Bearing Insert That Articulates With a Ceramic Femoral Head for THA)
In Brief
A clinical study evaluating COC 36mm for Non-inflammatory Degenerative Joint Disease and 3 related conditions. Completed, enrolled 172 participants across 13 sites in 2 countries.
Detailed Summary
This study is intended to gather short (Pre-operative to 4-years) and mid-term (5-years) information regarding the performance and safety of the commercially available 36mm CERAMAX® Ceramic on Ceramic Total Hip System from a cohort of new study subjects that were not previously involved in the IDE study for this device.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Post-Traumatic Osteoarthritis of Hip
CountriesCanada, United States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartJun 2014
Primary CompletionDec 2023
TodayJul 2026
First PostedMar 26, 2014
Enrollment StartJun 1, 2014
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 9.6 yearsPosted 12.3 years ago
Interventions
COC 36mmdevice
Total Hip Replacement with COC 36mm Acetabular Cup System