Trials / Completed
CompletedNCT00561600
Multi-Center Comparative Trial of the ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System
A Randomized, Prospective, Comparative, Multi-Center Clinical Evaluation of the DePuy ASR™-XL Acetabular Cup System vs. the Pinnacle™ Metal- on- Metal Total Hip System Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 265 (actual)
- Sponsor
- DePuy Orthopaedics · Industry
- Sex
- All
- Age
- 20 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this investigation is to evaluate the clinical and radiographic outcomes of the ASR™-XL Acetabular Cup System compared to the Pinnacle™ Acetabular Cup with a 28mm or 36mm ULTAMET™ metal insert.
Detailed description
The purpose of this clinical investigation is to gather sufficient clinical and radiographic data to permit valid scientific comparisons between treatment and control group outcomes. The treatment group/device for this study is the ASR™-XL Acetabular Cup System, and the control group/device is the Pinnacle™ Cup System w/ the 28mm or 36mm ULTAMET™ metal liner. The study objective will be achieved by way of treatment group selection, treatment administration, and management of participating study Subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ASR™-XL Modular Acetabular Cup System | The ASR™-XL Modular Acetabular Cup System treatment device is comprised of a metal acetabular cup, a unipolar femoral head and a taper sleeve adapter. |
| DEVICE | Pinnacle™ acetabular shell | The Pinnacle™ shells are cementless, titanium alloy cups with Porocoat® porous coating and HA DuoFix™ coating. There are various different liners available for use with the Pinnacle™ Acetabular Cup System. For the purpose of this investigation, the CoCrMo ULTAMET® 28mm or 36 mm metal liners will be used. |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2012-01-01
- Completion
- 2012-01-01
- First posted
- 2007-11-21
- Last updated
- 2017-08-09
- Results posted
- 2014-05-07
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00561600. Inclusion in this directory is not an endorsement.