Clinical trial NCT04666571: Personalised Against Standard High Tibial Osteotomy
Official title: Personalised Against Standard High Tibial Osteotomy, a Prospective Multi-centre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medial Knee Osteoarthritis
Lead sponsor: University of Bath
Sponsor class: OTHER
Collaborators: name: University of Oxford
name: 3D Metal Printing Ltd
name: Versus Arthritis
First posted: 2020-12-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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
measure: Phase 2 - To establish if digitally planned personalised HTO surgery (TOKA) increases the accuracy of bone correction in comparison to conventional HTO surgery.
timeFrame: 9 months post-randomisation (6 months post-surgery)
Secondary outcomes:
measure: Number of patients (%) achieving a pre-specified difference between planned and achieved coronal plane correction
timeFrame: 9 months post-randomisation (6 months post-surgery)
measure: Change in coronal plane location of peak loading during gait, in comparison to baseline, measured by Video Vector
timeFrame: 9 months post-randomisation (6 months post-surgery)
measure: Operative time in minutes
timeFrame: At procedure
measure: Patient reported outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Patient reported outcomes - EQ-5D-5L (EuroQol, 5 Dimension, 5 Levels)
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Patient reported outcomes - Visual analogue scale (VAS) pain score
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Patient reported outcomes - University of Carolina, Los Angeles Activity Score (UCLA Activity Score)
timeFrame: Baseline, 6 and 12 months post-surgery
measure: Patient reported outcomes - Satisfaction and transition
timeFrame: 6 and 12 months post-surgery
measure: Patient reported outcomes - Health resource use (visits to primary care and hospital care services)
timeFrame: 6 and 12 months post-surgery
measure: Knee range of motion (ROM)
timeFrame: 9 months post-randomisation (6 months post-surgery)
measure: Safety - rates of AEs / ADEs
timeFrame: Up to one year post-surgery
measure: Examine relationship between correction, change in loading and clinical outcomes (Calculated change in knee loading resulting from osteotomy correction from computer models of each patient).
timeFrame: 9 months post-randomisation (6 months post-surgery)
Other outcomes:
Locations:
city: Bath
country: United Kingdom
facility: Royal United Hospitals NHS Trust
state: Avon
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
state: Oxfordshire
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
state: Wales
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital
state: West Midlands
city: Walsall
country: United Kingdom
facility: Walsall Manor Hospital
state: West Midlands
city: Swindon
country: United Kingdom
facility: Great Western Hospital
state: Wiltshire
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter NHS Foundation Trust
Study officials:
affiliation: University of Bath
name: Richie Gill, Prof
role: PRINCIPAL_INVESTIGATOR
References: