Preheating of Femur Component in Hybrid Total Hip Arthroplasty

Study Overview
=================
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.

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.

Conditions
-----------------
Osteoarthritis, Hip

Intervention / Treatment
-----------------
* Procedure: Total hip replacement (Preheating of femur stem)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients suffering of hip osteoarthritis Exclusion Criteria: The patients with ASA score >II The patients with cancer The secondary coxarthrosis after the trauma Any vascular or neuromuscular diseases affecting the hip.

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Total hip replacement (Preheating of femur stem)|Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem migration in mm |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density g/cm2 |  | 2 years | 
| Temperature at bone-cement interface, degrees in Celsius |  | peroperatively | 
| Serum- Titanium measurements in blood samples |  | Not defined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty,, Hip,, Pre-heating,, Radiostereometric analysis,, Dual-Energy Radiographic Absorptiometry,