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

NCT01289834 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-04-18

No results posted yet for this study

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).

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

Sponsors & Collaborators

  • Aarhus University Hospital

    collaborator OTHER

  • Zimmer Biomet

    collaborator INDUSTRY

  • University of Aarhus

    lead OTHER

Principal Investigators

  • Kjeld Soballe, Professor MD · Orthopaedic Center, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
71 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2016-04-30
Completion
2024-01-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01289834 on ClinicalTrials.gov