Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319085
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2006-04-27
Brief Title:
Preheating of Femur Component in Hybrid Total Hip Arthroplasty
Sponsor:
Northern Orthopaedic Division Denmark
Organization:
Northern Orthopaedic Division Denmark
Study Overview
Official Title:
Comparison Between Preheated and Non-preheated Femur Component in Hybrid Total Hip Arthroplasty THA A Prospective Randomized Study of the 80 THA Using Radiostereometry
Status:
COMPLETED
Status Verified Date:
2015-04
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:
Background
Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components We will use the radiostereometry analysis RSA to investigate how the preheating of femur component influence on prosthesis survivorship There are no clinical controlled studies performed to the date
The aim of the study
Comparison of the migration rates between preheated and non-preheated femur components analyzed with RSA
Methods
Randomization of 80 patients into 2 groups with 40 in each All patients will undergo standard hybrid total hip replacement In group one the femur component Bi-Metric Interlock Biomet will be preheated to 40 degrees of Celsius before cementation In group two the control group the femur component will be of room temperature We will measure the temperature at cement bone interface during the operation with use of thermocouple electrodes inserted through separate drill hole in the femur The measurements will be recorded every 10 seconds The patients will follow the standard postoperative rehabilitation program
The RSA analysis will be performed the first day after the operation and at 3 12 24 months postoperatively
The Dual-energy X-ray absorptiometry scanning DEXA of the femur will be performed at the first week after the operation and at 12 and 24 months postoperatively
The patients will be followed both clinically and radiologically at 1 and 2 years after the operation Harris Hip Score
The results will be expressed as mean SD in mm ANOVA statistical analysis will be used to confirm the differences between the groups
Recently published studies confirm that preheating of femoral component enhances shear strength of implant-cement interface Both Iesaka et al 2003 and Jafri et al 2004 showed reduction in cement porosity on cement-implant interface with preheated femur components We will use the radiostereometry analysis RSA to investigate how the preheating of femur component influence on prosthesis survivorship There are no clinical controlled studies performed to the date
The aim of the study
Comparison of the migration rates between preheated and non-preheated femur components analyzed with RSA
Methods
Randomization of 80 patients into 2 groups with 40 in each All patients will undergo standard hybrid total hip replacement In group one the femur component Bi-Metric Interlock Biomet will be preheated to 40 degrees of Celsius before cementation In group two the control group the femur component will be of room temperature We will measure the temperature at cement bone interface during the operation with use of thermocouple electrodes inserted through separate drill hole in the femur The measurements will be recorded every 10 seconds The patients will follow the standard postoperative rehabilitation program
The RSA analysis will be performed the first day after the operation and at 3 12 24 months postoperatively
The Dual-energy X-ray absorptiometry scanning DEXA of the femur will be performed at the first week after the operation and at 12 and 24 months postoperatively
The patients will be followed both clinically and radiologically at 1 and 2 years after the operation Harris Hip Score
The results will be expressed as mean SD in mm ANOVA statistical analysis will be used to confirm the differences between the groups
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