Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-28 @ 12:08 AM
Study NCT ID:
NCT01289834
Status:
COMPLETED
Last Update Posted:
2024-04-18
First Post:
2010-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement
Sponsor:
University of Aarhus
Organization:
Study Overview
Official Title:
A Migration (RSA) and Bone Density (DEXA) Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement in Fixation of a Smooth vs. a Fine-blasted Femoral Stem. A Prospective Randomized Study on Primary Total Hip Arthroplasty.
Status:
COMPLETED
Status Verified Date:
2024-04
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:
The purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).
Detailed Description:
A randomized controlled clinical trial on 50 hybrid hips age above 70 years to the described two surgical procedures will be performed at Aarhus University hospital by two orthopaedic consultants. Randomization in 10 blocks of ten patients distributed with five patients for Palacos Cement and five patients for Hi-Fatigue Cement.
* 25 CPT femoral stems fixed with Hi-Fatigue Bone Cement.
* 25 CPT femoral stems fixed with Palacos Bone Cement.
All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.
* 25 CPT femoral stems fixed with Hi-Fatigue Bone Cement.
* 25 CPT femoral stems fixed with Palacos Bone Cement.
All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.
Study Oversight
Has Oversight DMC:
True
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?: