Trials / Completed
CompletedNCT02096211
Ceramic-on-Ceramic (COC) 36mm Acetabular Bearing Insert Post Approval Study-New Subjects (COC36mmPAS)
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 172 (actual)
- Sponsor
- DePuy Orthopaedics · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Up to 10 (up to 5 original IDE + 5 new sites) A prospective, non-controlled, non-randomized, multicenter study. Subjects will be seen for a clinic visit pre-operatively at the time of consent, (-90 days to surgery) and then at post-operatively at 6 weeks (1-92 days), 1 year (275-455 days), 2 years (640-820 days) and 3 years (1005-1185days), 4 years (1370-1550 days), and a minimum of 5 years (1825- 2555 days). Data collected will include: Pre-operatively subject history and demographics; Operative and device details; and Post-operatively Harris HIp scores, Subject Hip Outcomes, and Adverse Events. In order to optimize mid-term follow-up compliance, site personnel are permitted to contact the study subject in the 3 and 4 year intervals by phone (in place of a clinic visit) to assess the current status of the hip.
Conditions
- Non-inflammatory Degenerative Joint Disease
- Osteoarthritis
- Avascular Necrosis
- Post-Traumatic Osteoarthritis of Hip
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | COC 36mm | Total Hip Replacement with COC 36mm Acetabular Cup System |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2023-12-31
- Completion
- 2023-12-31
- First posted
- 2014-03-26
- Last updated
- 2025-07-16
- Results posted
- 2025-05-06
Locations
13 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02096211. Inclusion in this directory is not an endorsement.