Trials / Completed
CompletedNCT00754520
A Study Comparing Ceramic-on-metal Articulation to Metal-on-metal Articulation in Cementless Primary Hip Arthroplasty
A Multi-center Prospective Randomized Control Trial to Compare Two Articulating Bearing Surfaces, Ceramic-on-metal and Metal-on-metal as Used in Cementless Primary Hip Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 213 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup.
Detailed description
The aim of this study is to demonstrate the non-inferiority of the ceramic on metal articulation using M2a-38™ mm cup compared to the metal on metal articulation using the same cup in regards to the composite clinical success (CCS) rate, as defined in the protocol, at 2 year postoperative.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Ceramic On Metal | Ceramic on Metal articulation using M2a-38™ mm cup |
| DEVICE | Metal on Metal | Metal on Metal articulation using M2a-38™ mm cup |
Timeline
- Start date
- 2009-05-01
- Primary completion
- 2021-12-01
- Completion
- 2021-12-01
- First posted
- 2008-09-18
- Last updated
- 2024-10-02
- Results posted
- 2024-10-02
Locations
3 sites across 2 countries: Finland, United Kingdom
Source: ClinicalTrials.gov record NCT00754520. Inclusion in this directory is not an endorsement.