Personalised Against Standard High Tibial Osteotomy (NCT04666571) | Clinical Trial Compass
CompletedNot Applicable
Personalised Against Standard High Tibial Osteotomy
United Kingdom56 participantsStarted 2021-09-08
Plain-language summary
A study to compare the accuracy of achieving the planned correction between personalised (TOKA) high tibial osteotomy (HTO) procedure and standard generic HTO procedure.
Who can participate
Age range
18 Years – 65 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 undergoing High Tibial Osteotomy
* Male or Female, aged 18 to 65 years
* Primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD)
* Predominately diagnosed with unicompartmental medial osteoarthritis of the knee with the normal clinically acceptable level of other compartmental involvement
* Varus deformity \<20 °
* BMI ≤ 35. An exemption to this may be made if the participant (in the investigators opinion) is suitable for surgery.
* Participant is willing and able to give informed consent for participation in the study.
* Able (in the Investigators opinion) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.
Exclusion Criteria:
* Female participants who are pregnant, lactating or planning pregnancy during the course of the study.
* Prisoners
* Participants with a known deep tissue sensitivity to device materials
* Participants with an active or suspected latent infection in or about the affected knee joint
* Participants who have received any orthopaedic surgical intervention to the lower extremities (excluding investigative surgery) within the past 12 months, or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the HTO to be enrolled in this study, within the next 12 months (including intra-articular procedures).
* Participants who require bilateral HT…
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
Phase 1 - To assess the safety of the TOKA device by determining the incidence/rate of Adverse Events, Adverse Device Effects, Serious Adverse Device Effects, Serious Adverse Events, Unexpected Serious Adverse Device Effects and complications.
Timeframe: 6 weeks post-surgery
2
Phase 2 - To establish if digitally planned personalised HTO surgery (TOKA) increases the accuracy of bone correction in comparison to conventional HTO surgery.