Trials / Completed
CompletedNCT01828801
Pinnacle Metal-on-Metal 522 Post-Market Surveillance Study
Cross-Sectional, Multi-Center Evaluation of 8 Year Metal Ion Trends for Pinnacle MoM System Used in Primary Hip Arthroplasty
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 276 (actual)
- Sponsor
- DePuy Orthopaedics · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to evaluate blood metal ion levels as a function of time of implantation for the Pinnacle Acetabular MoM system.
Conditions
- Pinnacle Metal-on-Metal
- Revised Pinnacle Metal-on-Metal
- Adverse Local Tissue Reaction
- Metal Ions
- Total Hip Arthroplasty
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Pinnacle Metal-on Metal | All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2015-11-01
- Completion
- 2016-08-01
- First posted
- 2013-04-11
- Last updated
- 2016-09-26
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01828801. Inclusion in this directory is not an endorsement.