Personalised Against Standard High Tibial Osteotomy

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    93
  • sponsor
    University of Bath
Updated on 12 November 2021

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.

Description

The trial design is a multi-centre, blinded, superiority two arm, parallel group design randomised controlled trial (RCT) of personalised (TOKA) versus standard high tibial osteotomy (HTO).

The aim of the PASHiOn trial is to establish whether digitally planned personalised HTO surgery (TOKA) increases the accuracy of bone correction in comparison to conventional HTO surgery. Embedded within the trial is a non-randomised pre-RCT technology check and safety assessment of 5 patients (Phase 1), followed by a randomised controlled trial of 88 patients (Phase 2).

During phase 1 of the clinical investigation, 5 patients fulfilling the inclusion criteria will be recruited and assessed in an identical way to the 88 patients recruited in the main trial, but without randomisation. Recruitment of the remaining patients (Phase 2) will take place after the six-week assessment on the fifth patient is complete and the oversight committee supports progression to Phase 2.

Patients will be randomised to Phase 2 in a 1:1 ratio and patients will be blinded as to which treatment arm they receive.

Details
Condition Medial Knee Osteoarthritis
Treatment Tomofix, TOKA
Clinical Study IdentifierNCT04666571
SponsorUniversity of Bath
Last Modified on12 November 2021

Eligibility

Yes No Not Sure

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
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 suspended 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
Participants requiring bilateral HTO, or have a history of unsuccessful contralateral partial replacement or HTO
Chronic heart failure (NYHA Stage 2)
Neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device
Systemic disease diagnosis (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's disease) leading to progressive bone deterioration
Participant is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. > 30 days)
Participant is a smoker
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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