Status:
COMPLETED
A Migration and Bone Density Study Comparing 2 Types of Bone Cement in the OptiPac Bone Cement Mixing System
Lead Sponsor:
University of Aarhus
Collaborating Sponsors:
Aarhus University Hospital
Zimmer Biomet
Conditions:
Osteoarthritis
Eligibility:
All Genders
70+ years
Phase:
NA
Brief Summary
The goal of this scientific study is to determine whether there are differences in early migration and prosthesis-near bone density when a standard knee prosthesis is fixed with Refobacin Bone Cement ...
Detailed Description
Loosening of prosthetic components continues to play a large role in total knee alloplasty (TKA) and need for revision. Osteolysis is an important part of prosthesis loosening, but we still do not com...
Eligibility Criteria
Inclusion
- primary or secondary knee osteoarthritis
- sufficient bone quality for total knee arthroplasty
- age above 70 years
- no upper age limit if the patient is capable
- informed and written consent
- patient can only enter the project with one knee
Exclusion
- neuromuscular or vascular disease in the affected leg
- preoperatively not found suitable for a knee arthroplasty
- patients with osteoporosis based on former diagnosis or preoperative DEXA-scan
- fracture sequelae or previous PTO or previous extensive knee surgery
- patients with need of a stem-elongation
- patients who cannot refrain from taking NSAID post-operatively
- continuous medical treatment with vitamin K antagonists (Warfarin) which is known to reduce the bon emineral density by a factor of 5
- patients with metabolic bone disease
- patients with rheumatoid arthritis
- postmenopausal women in 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)
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00678236
Start Date
June 1 2008
End Date
June 1 2012
Last Update
August 20 2013
Active Locations (1)
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1
Orthopaedic Center, Aarhus University Hospital
Aarhus, Denmark, 8000