Ignite Creation Date:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-26 @ 4:09 AM
Study NCT ID:
NCT01319227
Status:
UNKNOWN
Last Update Posted:
2016-08-30
First Post:
2011-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Periprosthetic Bone Remodeling Around Uncemented Components in Total Hip Arthroplasty
Sponsor:
Danderyd Hospital
Organization:
Study Overview
Official Title:
Periprosthetic Bone Remodeling Around Two Different Types of Uncemented Femoral Stems and Two Uncemented Acetabular Components in Total Hip Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
PeriBRUSBRAC
Brief Summary:
This is a randomized clinical trial comparing two different uncemented femoral stems and two different uncemented sockets using Dual-energy x-ray absorptiometry, Radiostereometry and clinical evaluation.
Hypothesis:
1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
2. An uncemented acetabular component with a backside of three-dimensional Titanium porous construct gives less periprosthetic bone resorption than a backside covered with a conventional porous coating with Titanium-beads and a hydroxy-apatite layer.
Hypothesis:
1. A short uncemented stem gives less periprosthetic bone resorption in the proximal femur than a conventional uncemented stem.
2. An uncemented acetabular component with a backside of three-dimensional Titanium porous construct gives less periprosthetic bone resorption than a backside covered with a conventional porous coating with Titanium-beads and a hydroxy-apatite layer.
Detailed Description:
Consecutive patients 40-70 years old who are being planned for Total Hip Arthroplasty (THA) will be eligible for inclusion in the study.
Periprosthetic bone remodeling, migration of the components and clinical scores will be recorded prospectively.
Periprosthetic bone remodeling, migration of the components and clinical scores will be recorded prospectively.
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?: