Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-31 @ 11:34 AM
Study NCT ID:
NCT00588861
Status:
TERMINATED
Last Update Posted:
2017-01-27
First Post:
2007-12-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Shell Using Simplex® or Palacos® Bone Cement
Sponsor:
Biomet Orthopedics, LLC
Organization:
Study Overview
Official Title:
Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to insufficient data and lack of patient follow-up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.
Detailed Description:
The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.
Study Oversight
Has Oversight DMC:
False
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?: