NCT01289834

A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 71 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Hip Arthritis

Interventions

Type	Name	Description
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.
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

Timeline

• Start date: 2010-08-01
• Primary completion: 2016-04-01
• Completion: 2024-01-01
• First posted: 2011-02-04
• Last updated: 2024-04-18

Locations

1 site across 1 country: Denmark