Preheating of Femur Component in Hybrid Total Hip Arthroplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT00319085
First received: April 27, 2006
Last updated: March 28, 2014
Last verified: March 2014

April 27, 2006
March 28, 2014
May 2006
April 2010   (final data collection date for primary outcome measure)
Stem migration in mm [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Stem migration in mm
Complete list of historical versions of study NCT00319085 on ClinicalTrials.gov Archive Site
  • Bone mineral density g/cm2 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Temperature at bone-cement interface, degrees in Celsius [ Time Frame: peroperatively ] [ Designated as safety issue: No ]
  • Serum- Titanium measurements in blood samples [ Time Frame: Not defined ] [ Designated as safety issue: No ]
  • Bone mineral density g/cm2
  • Temperature at bone-cement interface, degrees in Celsius
  • Serum- Titanium measurements in blood samples
Not Provided
Not Provided
 
Preheating of Femur Component in Hybrid Total Hip Arthroplasty
Comparison Between Preheated and Non-preheated Femur Component in Hybrid Total Hip Arthroplasty (THA) A Prospective Randomized Study of the 80 THA Using Radiostereometry.

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

  • We will randomize 80 patients into 2 groups with 40 in each. All the 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- also 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 radiological 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoarthritis, Hip
Procedure: Total hip replacement (Preheating of femur stem)
Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2010
April 2010   (final data collection date for primary outcome measure)

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.
Both
70 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00319085
ON-04-008a-JPE
Yes
Northern Orthopaedic Division, Denmark
Northern Orthopaedic Division, Denmark
Not Provided
Principal Investigator: Mogens B Jørgensen, M.D. Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Principal Investigator: Mogens B Laursen, M.D., Ph.D Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Principal Investigator: Lotte Borgwardt, dr. Frederikberg Hospital, Copenhagen
Study Chair: Kjeld Søballe, Ph.D., MD. University Hospital of Aarhus
Study Director: Poul T Nielsen, M.D. Northern Orthopaedic Division, Aalborg University Hospital, Denmark
Northern Orthopaedic Division, Denmark
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP