Back to resultsA Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement
Primary Purpose
Hip Arthritis
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Hi-Fatigue Bone Cement
Palacos Bone Cement
Sponsored by
About this trial
This is an interventional treatment trial for Hip Arthritis focused on measuring RSA, Bone Cement
Eligibility 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)
Sites / Locations
- Kjeld Soballe, Orthopaedic center, University of Aarhus
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Hi-Fatigue Bone Cement
Palacos Bone Cement
Arm Description
CPT femoral stems fixed with Hi-Fatigue Bone Cement
CPT femoral stems fixed with Palacos Bone Cement
Outcomes
Primary Outcome Measures
Femoral component migration (roentgen stereo photogrammetric analysis - RSA)
Migration of the femoral component is measured over time and in respect to the femur bone.
Secondary Outcome Measures
Full Information
NCT ID
NCT01289834
First Posted
September 17, 2010
Last Updated
August 10, 2023
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Zimmer Biomet
1. Study Identification
Unique Protocol Identification Number
NCT01289834
Brief Title
A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement
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 Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2010 (Actual)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
January 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Zimmer Biomet
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Arthritis
Keywords
RSA, Bone Cement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hi-Fatigue Bone Cement
Arm Type
Active Comparator
Arm Description
CPT femoral stems fixed with Hi-Fatigue Bone Cement
Arm Title
Palacos Bone Cement
Arm Type
Active Comparator
Arm Description
CPT femoral stems fixed with Palacos Bone Cement
Intervention Type
Device
Intervention Name(s)
Hi-Fatigue Bone Cement
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Palacos Bone Cement
Intervention Description
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 Measure Information:
Title
Femoral component migration (roentgen stereo photogrammetric analysis - RSA)
Description
Migration of the femoral component is measured over time and in respect to the femur bone.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjeld Soballe, Professor MD
Organizational Affiliation
Orthopaedic Center, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kjeld Soballe, Orthopaedic center, University of Aarhus
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
A Migration and Bone Density Study Comparing Hi-Fatigue Bone Cement and Palacos Bone Cement
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