A Migration and Bone Density Study Comparing 2 Types of Bone Cement in the OptiPac Bone Cement Mi… (NCT00678236) | Clinical Trial Compass
CompletedNot Applicable
A Migration and Bone Density Study Comparing 2 Types of Bone Cement in the OptiPac Bone Cement Mixing System
Denmark54 participantsStarted 2008-06
Plain-language 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 R or with Refobacin Plus Bone Cement. Migration will be evaluated with RSA and bone density around the prosthesis with DEXA. The study will be successful if the prosthesis is fixed and remains in place throughout the entire period of the study, that is, that there is no increasing migration as measured by RSA. The cement type that ensures the largest number of solidly fixed prostheses during the two-year evaluation period will be "the best".
Who can participate
Age range
70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 Univ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.