Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00208468
Status:
TERMINATED
Last Update Posted:
2016-10-07
First Post:
2005-09-13
Brief Title:
A Randomised Multi-centre Study to Compare the Long-term Performance of the Future Hip to 3 Other Implants in Primary Total Hip Replacement
Sponsor:
DePuy International
Organization:
DePuy International
Study Overview
Official Title:
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
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow recruitment investigators not wishing to continue with randomisation and a decision to rationalise this product from the Sponsors portfolio
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None