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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01289834
Recruitment Status : Unknown
Verified October 2014 by University of Aarhus.
Recruitment status was:  Active, not recruiting
First Posted : February 4, 2011
Last Update Posted : October 22, 2014
Aarhus University Hospital
Zimmer Biomet
Information provided by (Responsible Party):
University of Aarhus

Brief 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).

Condition or disease Intervention/treatment Phase
Hip Arthritis Device: Hi-Fatigue Bone Cement Device: Palacos Bone Cement Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Study Start Date : August 2010
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   71 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • primary hip osteoarthritis
  • sufficient bone quality for total hip arthroplasty
  • age 71 years and above
  • no upper age limit if the patient is capable
  • informed and written consent
  • patient can only enter the project with one hip

Exclusion Criteria:

  • planned bilateral hip surgery
  • neuromuscular or vascular disease in the affected leg
  • preoperatively not found suitable for a hip arthroplasty
  • patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
  • fracture sequelae, osteonecrosis or previous extensive hip surgery
  • patients who cannot refrain from taking NSAID post-operatively
  • continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bone mass by a factor of 5
  • patients with metabolic bone disease
  • patients with rheumatoid arthritis
  • postmenopausal women in systemic estrogenic hormone substitution
  • patients with a continuous need of systemic cortisone treatment
  • non-Danish citizenship
  • patients who do not comprehend the Danish language (read and speak)
  • senile dementia
  • alcoholism - defined as men drinking more than 21 units a week and women drinking more than 14 units a week
  • drug abuse
  • major psychiatric disease
  • metastatic cancer disease and treatment with radiation therapy or chemotherapy
  • severe systemic disease (e.g. hemi paresis and Parkinson disease)
  • systemic hip and spine disease
  • employee at the orthopaedic department, Aarhus University Hospital
  • ongoing case regarding industrial injury insurance of the knee
  • patients with poor dental status (risk of infection)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01289834

Kjeld Soballe, Orthopaedic center, University of Aarhus
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Zimmer Biomet
Principal Investigator: Kjeld Soballe, Professor MD Orthopaedic Center, Aarhus University Hospital

Responsible Party: University of Aarhus Identifier: NCT01289834     History of Changes
Other Study ID Numbers: VEK20100112
First Posted: February 4, 2011    Key Record Dates
Last Update Posted: October 22, 2014
Last Verified: October 2014

Keywords provided by University of Aarhus:
Bone Cement

Additional relevant MeSH terms:
Signs and Symptoms