Preheating of Femur Component in Hybrid Total Hip Arthroplasty
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00319085|
Recruitment Status : Completed
First Posted : April 27, 2006
Last Update Posted : April 10, 2015
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Hip||Procedure: Total hip replacement (Preheating of femur stem)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
- Procedure: Total hip replacement (Preheating of femur stem)
Total hybrid hip arthroplasty, cementation of femural component, preheating, radiostereometry, DEXA
- Stem migration in mm [ Time Frame: 2 years ]
- Bone mineral density g/cm2 [ Time Frame: 2 years ]
- Temperature at bone-cement interface, degrees in Celsius [ Time Frame: peroperatively ]
- Serum- Titanium measurements in blood samples [ Time Frame: Not defined ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319085
|Farsoe Hospital, Northern Orthopaedic Division|
|Farsoe, Denmark, 9640|
|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|