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

This study is currently recruiting participants.
Verified August 2013 by University of Aarhus
Sponsor:
Collaborators:
Aarhus University Hospital
Zimmer, Inc.
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01289834
First received: September 17, 2010
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Hip Arthritis
Device: Hi-Fatigue Bone Cement
Device: Palacos Bone Cement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Femoral component migration (roentgen stereo photogrammetric analysis - RSA) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Migration of the femoral component is measured over time and in respect to the femur bone.


Estimated Enrollment: 50
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   71 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01289834

Contacts
Contact: Maiken Stilling, MD, PhD 0045 89497466 maiken.stilling@ki.au.dk

Locations
Denmark
Kjeld Soballe, Orthopaedic center, University of Aarhus Recruiting
Aarhus, Denmark, 8000
Contact: Maiken Stilling, MD, PhD    0045 89497466    maiken.stilling@ki.au.dk   
Sub-Investigator: Martin Lamm, MD         
Sub-Investigator: Henrik Daugaard, MD         
Sub-Investigator: Michael Ulrich-Vinter, MD, PhD         
Sub-Investigator: Maiken Stilling, MD, PhD         
Sponsors and Collaborators
University of Aarhus
Aarhus University Hospital
Zimmer, Inc.
Investigators
Principal Investigator: Kjeld Soballe, Professor MD Orthopaedic Center, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01289834     History of Changes
Other Study ID Numbers: VEK20100112
Study First Received: September 17, 2010
Last Updated: August 19, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
RSA
Bone Cement

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on April 16, 2014