Five-year Migration Pattern and Bone Mineral Density for the Tri-Lock and Summit Femoral Stems. (NCT06019026) | Clinical Trial Compass
CompletedNot Applicable
Five-year Migration Pattern and Bone Mineral Density for the Tri-Lock and Summit Femoral Stems.
52 participantsStarted 2015-01-01
Plain-language summary
The incidence of primary hip joint prosthesis is 180 per. 100,000 inhabitants. In male patients younger than 50 years the 10-years survival of the prosthesis is 89 % and 82 % over 15 years. In women younger than 50 years the 10-years survival of the prosthesis is 87 % and 78 % over 15 years.
As revision surgery is associated with higher complication risk for the patient and poorer out-come and implant survival it is necessary to examine possible methods that may increase long-term survival of the primary hip prosthesis or facilitate better outcomes after revision of hip joint prostheses for younger patients.
In younger patients the prosthesis often is inserted without the use of cement. When not using cement, it is crucial for the final result, that there is a direct bone ingrowth of the prosthesis. The chance of getting bone ingrowth depends firstly on a good immediate mechanical fixation at surgery and secondly on osteoconductive abilities of the prosthetic surface.
This study investigates a new bone sparing implant with a new surface compared to a conventional implant.
Who can participate
Age range
40 Years – 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
. Patients with primary hip osteoarthritis
. Patients with adequate bone stock for insertion of uncemented components(no osteoporosis as assessed by pre-operative dual-energy x-ray absorptiometry (DXA) scans)
. Informed, written consent
Exclusion criteria
. Patients with neuromuscular or vascular diseases in the affected leg
. Patients intraoperatively found unfit to uncemented components
. Patients who can not refrain from the use of non-steroidal anti-inflammatory drugs (NSAIDs) in post-operative recovery
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.
What they're measuring
1
Migration (3D rotation and translation) Measured with radiostereometric analysis (RSA)
Timeframe: 5 years
2
Bone mineral density (BMD) measured with dual-energy x-ray absorptiometry