Clinical trial NCT00319085: Preheating of Femur Component in Hybrid Total Hip Arthroplasty
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Hip
Keywords: Arthroplasty,
Hip,
Pre-heating,
Radiostereometric analysis,
Dual-Energy Radiographic Absorptiometry,
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Stem migration in mm
timeFrame: 2 years
Secondary outcomes:
measure: Bone mineral density g/cm2
timeFrame: 2 years
measure: Temperature at bone-cement interface, degrees in Celsius
timeFrame: peroperatively
measure: Serum- Titanium measurements in blood samples
timeFrame: Not defined
Other outcomes:
Locations:
city: Farsoe
country: Denmark
facility: Farsoe Hospital, Northern Orthopaedic Division
Study officials:
affiliation: Northern Orthopaedic Division, Aalborg University Hospital, Denmark
name: Mogens B Jørgensen, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Northern Orthopaedic Division, Aalborg University Hospital, Denmark
name: Mogens B Laursen, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Frederikberg Hospital, Copenhagen
name: Lotte Borgwardt, dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Aarhus
name: Kjeld Søballe, Ph.D., MD.
role: STUDY_CHAIR
affiliation: Northern Orthopaedic Division, Aalborg University Hospital, Denmark
name: Poul T Nielsen, M.D.
role: STUDY_DIRECTOR
References: