Preheating of Femur Component in Hybrid Total Hip Arthroplasty

Osteoarthritis, Hip Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00319085
• Other study ID #: ON-04-008a-JPE
• Status: Completed
• Phase: Phase 2
• First received: April 27, 2006
• Last updated: April 9, 2015
• Start date: May 2006
• Est. completion date: April 2010

Study information

• Verified date: April 2015
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Hip

Intervention

Procedure:
• Total hip replacement (Preheating of femur stem)
Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA

Locations

Country	Name	City	State
Denmark	Farsoe Hospital, Northern Orthopaedic Division	Farsoe

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stem migration in mm		2 years	No
Secondary	Bone mineral density g/cm2		2 years	No
Secondary	Temperature at bone-cement interface, degrees in Celsius		peroperatively	No
Secondary	Serum- Titanium measurements in blood samples		Not defined	No