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

NACompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

August 31, 2010

Primary Completion Date

April 30, 2016

Study Completion Date

January 31, 2024

Conditions
Hip Arthritis
Interventions
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"

Trial Locations (1)

8000

Kjeld Soballe, Orthopaedic center, University of Aarhus, Aarhus

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aarhus University Hospital

OTHER

collaborator

Zimmer Biomet

INDUSTRY

lead

University of Aarhus

OTHER