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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.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00319085
Enrollment
80
Registered
2006-04-27
Start date
2006-05-31
Completion date
2010-04-30
Last updated
2015-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

Keywords

Arthroplasty,, Hip,, Pre-heating,, Radiostereometric analysis,, Dual-Energy Radiographic Absorptiometry,

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.

Interventions

PROCEDURETotal hip replacement (Preheating of femur stem)

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

Sponsors

Northern Orthopaedic Division, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
70 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Stem migration in mm2 years

Secondary

MeasureTime frame
Bone mineral density g/cm22 years
Temperature at bone-cement interface, degrees in Celsiusperoperatively
Serum- Titanium measurements in blood samplesNot defined

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026