Preheating of Femur Component in Hybrid Total Hip Arthroplasty

NCT ID: NCT00319085

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31
• Study Completion Date: 2010-04-30

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.

Conditions

Osteoarthritis, Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Total hip replacement (Preheating of femur stem)

Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 70 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mogens B Jørgensen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Division, Aalborg University Hospital, Denmark

Mogens B Laursen, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Division, Aalborg University Hospital, Denmark

Lotte Borgwardt, dr.

Role: PRINCIPAL_INVESTIGATOR

Frederikberg Hospital, Copenhagen

Kjeld Søballe, Ph.D., MD.

Role: STUDY_CHAIR

University Hospital of Aarhus

Poul T Nielsen, M.D.

Role: STUDY_DIRECTOR

Northern Orthopaedic Division, Aalborg University Hospital, Denmark

Locations

Farsoe Hospital, Northern Orthopaedic Division

Farsø, , Denmark

Countries

Denmark

Other Identifiers

ON-04-008a-JPE

Identifier Type: -

Identifier Source: org_study_id