Trials / Terminated
TerminatedNCT00546598
Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System
DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System PMA Post-approval Study
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 106 (actual)
- Sponsor
- DePuy Orthopaedics · Industry
- Sex
- All
- Age
- 21 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.
Detailed description
This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase. The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of: 1. a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and 2. a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.
Conditions
- Non-inflammatory Joint Disease
- Osteoarthritis
- Avascular Necrosis
- Congenital Hip Dysplasia
- Post-traumatic Arthritis
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total hip replacement/arthroplasty | Hip replacement |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2014-04-01
- Completion
- 2014-04-01
- First posted
- 2007-10-19
- Last updated
- 2021-11-30
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00546598. Inclusion in this directory is not an endorsement.