PASHiOn: Personalised Against Standard High tibial Osteotomy, a prospective multi-centre randomised controlled trial
High tibial Osteotomy for osteoarthritis of the knee
Current interventions as of 29/03/2023: Embedded within the trial is a non-randomised pre-trial technology check and safety assessment, this is termed the Initial Safety Phase (Phase 1). During this stage of the clinical investigation, 5 patients fulfilling the inclusion criteria will be recruited and assessed in an identical way to the patients recruited in the main trial, but without randomisation. The 5 participants will receive the interventional device – Tailored Osteotomy Knee Alignment (TOKA). In Phase 2, the main randomised control trial, patients will be randomised in a 1:1 ratio to recieve either personalised (TOKA) or conventional HTO (Tomofix or ActivMotion) surgery. Recruitment of the remaining patients to Phase 2 will take place after the six-week assessment on the fifth patient in Phase 1 is complete, and the oversight committee supports progression to Phase 2. Patients and primary outcome assessors will be blinded to the allocation. All patients will receive a high tibial osteotomy (HTO) as a single surgical intervention. A high tibial osteotomy is a surgical procedure to realign the leg. A cut is made in the tibia and the alignment of the tibia is carefully adjusted by levering open this cut in the bone until the desired alignment is reached. The bone is then fixed with a plate that is held in place with screws. This is called an ‘opening wedge osteotomy’. The osteotomy gap in the bone will fill in with new bone over the next few months post-surgery. During surgery, patients will either receive the standard HTO procedure (the Tomofix or ActivMotion plate) or the personalised 3D printed HTO procedure (TOKA). As part of routine care, patients will receive the usual NHS treatment and aftercare. The Baseline assessment will be undertaken once the patients’ eligibility and willingness to participate has been confirmed and the patient has provided Informed Consent. No study specific activities will take place prior to receiving Informed Consent. Bas
Current participant inclusion criteria as of 29/03/2023: 1. Undergoing High Tibial Osteotomy 2. Male or female, aged between 18 and 65 years 3. Primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD) 4. Predominately diagnosed with unicompartmental medial osteoarthritis of the knee with the normal clinically acceptable level of other compartmental involvement 5. Varus deformity 6. BMI ≤35. An exemption to this may be made if the participant (in the investigator's opinion) is suitable for surgery. 7. Willing and able to give informed consent for participation in the study 8. Able (in the Investigators opinion) and willing to comply with all study requirements 9. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the study Previous participant inclusion criteria: 1. Undergoing High Tibial Osteotomy 2. Male or female, aged between 18 and 65 years 3. Primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD) 4. Predominately diagnosed with unicompartmental medial osteoarthritis of the knee with the normal clinically acceptable level of other compartmental involvement 5. Varus deformity <20° 6. BMI ≤35 7. Willing and able to give informed consent for participation in the study 8. Able (in the Investigators opinion) and willing to comply with all study requirements 9. Willing to allow their General Practitioner and consultant, if appropriate, to be notified of participation in the study
Current participant exclusion criteria as of 29/03/2022: 1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study. 2. Prisoners 3. Participants with a known deep tissue sensitivity to device materials 4. Participants with an active or suspected latent infection in or about the affected knee joint 5. 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). 6. Participants who require bilateral HTO with surgery planned on their second knee within 6 months of their first operation (bilateral HTO patients are otherwise included). 7. Participants who require bilateral HTO who have a previous unsuccessful contralateral partial replacement or HTO. 8. Chronic heart failure (NYHA Stage ≥ 2) 9. Neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device 10. Systemic disease diagnosis (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget’s disease) leading to progressive bone deterioration. 11. Participant is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days). 12. Participant is a smoker. 13. 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, or may influence the result of the study, or the participant’s ability to participate in the study Previous participant exclusion criteria: 1. Pregnant, lactating, or planning a pregnancy during the course of the study 2. Prisoners 3. Known deep tissue sensitivity to device materials 4. Active or suspended latent infection in or about the affected knee jo