Personalised Against Standard High Tibial Osteotomy (PASHiOn)

University of Bath

Status: Active, not recruiting

Conditions: Medial Knee Osteoarthritis

Treatments: Device: Tomofix or ActivMotion; Device: TOKA

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04666571

OCTRU263

Details and patient eligibility

About

A study to compare the accuracy of achieving the planned correction between personalised (TOKA) high tibial osteotomy (HTO) procedure and standard generic HTO procedure.

Full 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 (revised to 50) 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 (revised to 50) 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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 HTO with surgery planned on their second knee within 6 months of their first operation (bilateral HTO patients are otherwise included).
• Participants who require bilateral HTO who have had a previous 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 2 patient groups

Personalised (TOKA)

Experimental group

Description:

During HTO surgery, the personalised plate will be inserted below the knee. The investigational device and comparator are two types of metal plate used to fix the bone in place during a high tibial osteotomy (HTO).

Treatment:

Device: TOKA

Standard (Tomofix or ActivMotion)

Active Comparator group

Description:

During HTO surgery, the standard plate will be inserted below the knee.

Treatment:

Device: Tomofix or ActivMotion