Clinical Trials Directory

Trials / Terminated

TerminatedNCT00208468

A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement

A Multi-centre, Randomised, Parallel Group, Controlled Study to Compare the Performance of the Future Hip Against Three Currently Used Implants in Total Hip Replacement

Status
Terminated
Phase
Phase 3
Study type
Interventional
Enrollment
317 (actual)
Sponsor
DePuy International · Industry
Sex
All
Age
55 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This post-market clinical follow-up study was designed to compare hip replacement outcomes of the European Hip against 3 controls (Omniflex, Zweymuller, and Spotorno), however Omniflex did not end up being used. The first patient had surgery on February 18, 2000 and the final patient had surgery on September 2, 2005. There were 317 subjects consented but only 301 had hip replacement surgery (subjects received: 220 European hips, 33 Zweymuller, and 48 Spotorno). The study took place at three sites. Each site used their standard device as the control. The Austrian site enrolled 69 European hips and 33 Zweymuller hips. 92 European hips and 48 Spotorno hips were enrolled in Germany. Finally, the site in Italy enrolled 59 European hips. Although the study protocol intended collecting DEXA and RSA outcomes, the data collected by the sites did not include these outcomes.

Conditions

Interventions

TypeNameDescription
DEVICEEuropean HipA cementless femoral component for use in total hip replacement
DEVICEZweymüllerA cementless femoral component for use in total hip replacement
DEVICECLS SpotornoA cementless femoral component for use in total hip replacement

Timeline

Start date
2000-02-01
Primary completion
2005-06-01
Completion
2015-03-01
First posted
2005-09-21
Last updated
2016-10-07

Locations

3 sites across 3 countries: Austria, Germany, Italy

Source: ClinicalTrials.gov record NCT00208468. Inclusion in this directory is not an endorsement.