Comparison of Oxford UKA and Sigma UKA With RSA. (NCT03434600) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Oxford UKA and Sigma UKA With RSA.
61 participantsStarted 2014-01
Plain-language summary
Comparison of two unicompartmental knee arthroplasties (UKA), to see if Sigma UKA performs equally good as the Oxford UKA. The study focuses on how well the arthroplasty is fixated to the bone and on the difference in wear of the plastic insert. Finally, the functional outcome after surgery is compared between the two arthroplasties.
Hypothesis:
H1: The Sigma UKA has an equal migration pattern compared to the Oxford UKA with a follow up of two years - that is, no significant difference in migration between 1-2 years follow-up.
H2: The Oxford and Sigma UKA's have comparable polyethylene wear with a follow up of 5 years.
H3: The Oxford and Sigma UKA's have comparable patient perceived outcome measures (PROM) and leg extension power (LEP) postoperative.
H4: BMD of the proximal tibia does not influence migration of the tibial component
Who can participate
Age range
18 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:
* All eligable patients with medial osteoarthritis of the knee.
Exclusion Criteria:
* \- Inflammatory arthritis.
* Patients who are not able to participate in the fast-track surgery program.
* Patients with a contralateral knee arthroplasty.
* Patients who are unable to provide informed consent.
* Disseminated malignant disease (cancer) and treatment with radiation or chemotherapy.
* Serious systemic disease (e.g.. hemiparesis and severe parkinsonism)
* On-going case involving work injury of the knee.
* Female patients with a wish of becoming pregnant in the study period.
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.