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 range18 Years – 65 Years
SexALL
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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…
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.