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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
| Zimmer Biomet | INDUSTRY |
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The purpose of this scientific study is to compare early migration of hip prostheses in respect to the bone in order to determine whether there is a clinical difference between the two investigated bone cements (which one is best suited for cementation of hip prostheses).
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.
All patients will be operated by the postero-lateral approach. The post-operative treatment and training will not differ from the standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hi-Fatigue Bone Cement | Active Comparator | CPT femoral stems fixed with Hi-Fatigue Bone Cement |
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| Palacos Bone Cement | Active Comparator | CPT femoral stems fixed with Palacos Bone Cement |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hi-Fatigue Bone Cement | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Femoral component migration (roentgen stereo photogrammetric analysis - RSA) | Migration of the femoral component is measured over time and in respect to the femur bone. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kjeld Soballe, Professor MD | Orthopaedic Center, Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kjeld Soballe, Orthopaedic center, University of Aarhus | Aarhus | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36422666 | Derived | Jorgensen PB, Krag-Nielsen N, Lindgren L, Morup RMS, Kaptein B, Stilling M. Radiostereometric analysis: comparison of radiation dose and precision in digital and computed radiography. Arch Orthop Trauma Surg. 2023 Sep;143(9):5919-5926. doi: 10.1007/s00402-022-04674-0. Epub 2022 Nov 23. |
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| Palacos Bone Cement | Device | 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 |
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