Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT00293605
Status:
COMPLETED
Last Update Posted:
2011-05-09
First Post:
2006-02-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Organization:
Study Overview
Official Title:
Effect of Cemented Stem Design on Periprosthetic Bone Mass Following Primary Total Hip Arthroplasty
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Total hip replacement is a common procedure for the treatment of osteoarthrosis of the hips, the aims of this study are to determine the effect of implant stem design on bone quality surrounding the implant using three stem designs that are routinely implanted at this hospital.
Detailed Description:
120 patients will undergo routine hip replacements using either the C-Stem, Exeter Stem or Charnley stem implants. Patients will be clinically evaluated pre-operatively and randomised to one of the three implants. Post-operatively, patients will be clinically reviewed for 2 years using bone mineral density scans, radiological review, blood and urine analysis for bone markers and validated questionnaires to assess clinical data (Oxford Hip and Harries Hip). Patients will be assessed for prothesis migration using the EBRA methods.
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?: