A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement
Recruitment status was: Active, not recruiting
|Hip Arthritis||Device: Hi-Fatigue Bone Cement Device: Palacos Bone Cement||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||A Migration (RSA) and Bone Density (DEXA) Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement in Fixation of a Smooth vs. a Fine-blasted Femoral Stem. A Prospective Randomized Study on Primary Total Hip Arthroplasty.|
- Femoral component migration (roentgen stereo photogrammetric analysis - RSA) [ Time Frame: 2 years ]Migration of the femoral component is measured over time and in respect to the femur bone.
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||April 2017|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Hi-Fatigue Bone Cement
CPT femoral stems fixed with Hi-Fatigue Bone Cement
Device: Hi-Fatigue Bone Cement
Hi-Fatigue bone cement is a new development of Aap Biomaterials, GmbH & Co that has not yet been tested in the clinical setting. Hi-Fatigue has a medium to low viscosity. Laboratory tests confirm Hi-Fatigue bone cement to have properties equivalent to or better than the golden standard bone cement" Palacos. Hi-Fatigue is to be used without pre-chilling. When mixed at a room temperature of 21°C Hi-Fatigue has a low initial viscosity improving mixing and theoretically reducing the porosity of the cured cement.
Active Comparator: Palacos Bone Cement
CPT femoral stems fixed with Palacos Bone Cement
Device: Palacos Bone Cement
Palacos Bone Cement has been used for 48 years and has a good reputation as the "gold standard" among bone cements (3). It is a high-viscosity cement with rapid application that makes it advantageous for use in orthopedic joint surgery. Palacos cement was developed in order to allow hand mixing of monomers and polymers in a dish in the operating room. Air pollution with toxic monomers in the operating room was a problem that was primarily solved by exhaust ventilation, later supplemented with vacuum mixing
A randomized controlled clinical trial on 50 hybrid hips age above 70 years to the described two surgical procedures will be performed at Aarhus University hospital by two orthopaedic consultants. Randomization in 10 blocks of ten patients distributed with five patients for Palacos Cement and five patients for Hi-Fatigue Cement.
- 25 CPT femoral stems fixed with Hi-Fatigue Bone Cement.
- 25 CPT femoral stems fixed with Palacos Bone Cement.
All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289834
|Kjeld Soballe, Orthopaedic center, University of Aarhus|
|Aarhus, Denmark, 8000|
|Principal Investigator:||Kjeld Soballe, Professor MD||Orthopaedic Center, Aarhus University Hospital|