Personalised Against Standard High Tibial Osteotomy

NCT04666571 | Completed DMC

• 1 other identifier: OCTRU263
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

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.

Conditions

Medial Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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.

  Incidence/rate of safety events - Adverse Events (AE), Adverse Device Effects (ADE), Serious Adverse Device Effects (SADEs), Serious Adverse Events (SAEs), Unexpected Serious Adverse Device Effects (SADEs) and complications.

  6 weeks post-surgery

• Phase 2 - To establish if digitally planned personalised HTO surgery (TOKA) increases the accuracy of bone correction in comparison to conventional HTO surgery.

  The absolute difference between planned and achieved coronal plane correction in terms of the hip-knee-ankle angle, (as measured from full length weight bearing x-rays)

  9 months post-randomisation (6 months post-surgery)

Secondary Outcomes (12)

• Number of patients (%) achieving a pre-specified difference between planned and achieved coronal plane correction

  9 months post-randomisation (6 months post-surgery)

• Change in coronal plane location of peak loading during gait, in comparison to baseline, measured by Video Vector

  9 months post-randomisation (6 months post-surgery)

• Operative time in minutes

  At procedure

• Patient reported outcomes - Knee Injury and Osteoarthritis Outcome Score (KOOS)

  Baseline, 6 and 12 months post-surgery

• Patient reported outcomes - EQ-5D-5L (EuroQol, 5 Dimension, 5 Levels)

  Baseline, 6 and 12 months post-surgery

Study Arms (2)

Personalised (TOKA)

EXPERIMENTAL

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).

Device: TOKA

Standard (Tomofix or ActivMotion)

ACTIVE COMPARATOR

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

Device: Tomofix or ActivMotion

Interventions

TOKA DEVICE

The device is a digitally planned (using individual CT scan measured anatomic data) personalised opening wedge high tibial osteotomy (HTO) procedure using a custom 3D printed surgical guide and plate.

Also known as: Tailored Osteotomy Knee Alignment, Personalised HTO

Personalised (TOKA)

Tomofix or ActivMotion DEVICE

The comparators, Tomofix and ActivMotion, are the most widely used devices for HTO procedures in the UK. Surgical procedures using the Tomofix and ActiveMotion are similar to TOKA, however, they are not patient specific and do not use custom-made plates.

Also known as: Standard HTO, Generic HTO

Standard (Tomofix or ActivMotion)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Bath: lead
• University of Oxford: collaborator
• 3D Metal Printing Ltd: collaborator
• Versus Arthritis: collaborator

Study Sites (7)

Royal United Hospitals NHS Trust

Bath, Avon, BA1 3NG, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, Oxfordshire, OX3 7HE, United Kingdom

Location

Cardiff and Vale University Health Board

Cardiff, Wales, CF14 4XW, United Kingdom

Location

Royal Orthopaedic Hospital

Birmingham, West Midlands, B31 2AP, United Kingdom

Location

Walsall Manor Hospital

Walsall, West Midlands, WS2 9PS, United Kingdom

Location

Great Western Hospital

Swindon, Wiltshire, SN3 6BB, United Kingdom

Location

Royal Devon and Exeter NHS Foundation Trust

Exeter, United Kingdom

Location

Study Officials

• Richie Gill, Prof

  University of Bath

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Healthcare Engineering

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 14, 2020
• Study Start: September 8, 2021
• Primary Completion: December 6, 2024
• Study Completion: July 10, 2025
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (7)