Total Versus Robotic Assisted Unicompartmental Knee Replacement (NCT05290818) | Clinical Trial Compass
RecruitingNot Applicable
Total Versus Robotic Assisted Unicompartmental Knee Replacement
United Kingdom159 participantsStarted 2024-08-26
Plain-language summary
The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.
Who can participate
Age range
50 Years – 75 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:
* Listed for elective primary TKA for end stage medial compartment osteoarthritis
* Intact anterior cruciate ligament
* Full thickness and good quality lateral cartilage
* Correctable intra-articular varus deformity and intact medial collateral ligament
* American Society of Anesthesiologists (ASA) grades 1 and 2
* Male or female, age 50 - 75 at the time of listing for surgery
* Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA
Exclusion Criteria:
* Varus deformity of \> 20 degrees
* Fixed flexion of \>10 degrees
* Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments
* Female participants who are pregnant, lactating or planning pregnancy during the course of the study
* Requires patella resurfacing or lateral compartment has significant OA
* Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
* Inflammatory disorder e.g. rheumatoid arthritis
* Symptomatic foot, hip or spine pathology
* Prior surgery (other than arthroscopy) or septic arthritis of the knee
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,
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.