Trials / Terminated
TerminatedNCT05357664
PINNACLE® DM RSA Study
Multi-Center, Non-Controlled, Prospective Radiostereometric Analysis of the PINNACLE® Dual Mobility Construct
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- DePuy Orthopaedics · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. Additionally, the data from this study will be compared to historical PINNACLE® data obtained in study DSJ\_2018\_02.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Total Hip Arthroplasty | Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses |
| DEVICE | Revision Total Hip Arthroplasty | Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses |
Timeline
- Start date
- 2022-10-06
- Primary completion
- 2022-12-20
- Completion
- 2023-02-09
- First posted
- 2022-05-03
- Last updated
- 2024-04-18
- Results posted
- 2024-04-18
Locations
3 sites across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05357664. Inclusion in this directory is not an endorsement.