CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 265 enrolled
Drug / intervention
ASR™-XL Modular Acetabular Cup System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00561600
NCT00561600N/ACompleted
CompareCT.gov

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

DePuy Orthopaedics·interventional·Posted Nov 21, 2007·Updated Aug 9, 2017

In Brief

A clinical study evaluating ASR™-XL Modular Acetabular Cup System and Pinnacle™ acetabular shell for Non-inflammatory Degenerative Joint Disease. Completed, enrolled 265 participants across 8 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-inflammatory Degenerative Joint Disease
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 21, 2007
Enrollment StartNov 1, 2006
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 18.6 years ago

Interventions

ASR™-XL Modular Acetabular Cup Systemdevice

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.

Pinnacle™ acetabular shelldevice

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.