Personalised HTO Versus Generic HTO Virtual Clinical Trial

NCT ID: NCT03419598

Last Updated: 2020-12-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-03
• Study Completion Date: 2019-06-28

Brief Summary

High Tibial Osteotomy (HTO) is an alternative to knee replacement in suitable patients with early knee osteoarthritis (OA), it is particularly suited to patients with single compart disease who otherwise would be suitable for unicompartmental knee replacement (UKR). OA of the knee is very common and increasing driven by the ageing of the population. The current limitations of HTO are related to the difficulty of achieving the desired correction due to a challenging surgical technique and soft tissue irritation due to the use of generic stabilisation plates. This study will examine the safety equivalence of a new patient specific HTO process which has patient specific 3D printed plates, i.e. personalised HTO plates, with the existing most commonly used HTO procedure using the Tomofix generic HTO plate. Importantly this study will be undertaken as a Virtual Trial, existing anonymised 3D imaging data will be used to create the virtual patient cohort. This cohort will receive both procedures, which for this type of procedure is only possible in a virtual scenario.

The main question to be addressed is: "Is the personalised HTO procedure as safe as the most commonly used existing generic HTO procedure?". In this context safety concerns the mechanical loads placed upon the tibia and the support plate.

The interventions will all be made on computer models, the 3D imaging data will be used to create the intact (un-operated) models of the subject tibias. Each model will then be virtually operated upon, with both the personalised and generic HTO procedures. The models will then be loaded with physiological loads experienced during function and the mechanical states compared.

Detailed Description

Ethical approval was obtained to use CT scans of 30 patients with moderate to severe knee arthritis (REC reference: 17/HRA/0033, Royal Devon & Exeter National Health Service [NHS], UK).

The CT data will be used to generate the 3D geometry of each patient's proximal tibia. The osteotomy correction angle required for each patient such that the altered mechanical axis will pass through a point 62.5% of the distance from medial to lateral tibial plateau. Virtual HTO surgery will be performed on each patient to alter the mechanical axis of the knee by creating an opening wedge osteotomy.

After the virtual surgeries are performed, each virtual patient will be duplicated. One copy will have the osteotomy stabilised using a Generic plate and the other using a Personalised plate, thus forming the two arms of the trial.

For each participant in each arm finite element (FE) models will be created, and loads applied simulating walking, sit to stand and squatting. Four healings stages will be considered, stage 1 being immediately post-operation (this will not be modelled), stage 2 representing 2 weeks post-operation, stage 3 representing 6 weeks and stage 4 representing 12 weeks. The mechanical loads in the plates, and around the screw locations in the bone, will be established by solving these finite element models.

Conditions

Osteoarthritis, Knee

Keywords

virtual clinical trial; high tibial osteotomy; 3D; computer simulation; finite element analysis; medial unicompartmental knee osteoarthritis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

All study participants

All virtual participants who received a virtual opening wedge high tibial osteotomy. The baseline information was the individual CT-based geometry of tibia.

Opening wedge high tibial osteotomy

Intervention Type: PROCEDURE

Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia. Since this is a virtual trial, the virtual patients were duplicated and enrolled into both arms

Personalised subject specific custom HTO plate

Intervention Type: DEVICE

Subject specific custom plate for stabilizing an open wedge HTO

Generic HTO plate

Intervention Type: DEVICE

Generic plate for stabilizing an open wedge HTO

Interventions

Opening wedge high tibial osteotomy

Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia. Since this is a virtual trial, the virtual patients were duplicated and enrolled into both arms

Intervention Type: PROCEDURE

Personalised subject specific custom HTO plate

Subject specific custom plate for stabilizing an open wedge HTO

Intervention Type: DEVICE

Generic HTO plate

Generic plate for stabilizing an open wedge HTO

Intervention Type: DEVICE

Other Intervention Names

HTO; Personalised plate; Generic plate

Eligibility Criteria

Inclusion Criteria

• Appropriate existing CT data of lower limb.
• Male or Female, aged 18 years or above.
• Diagnosed with moderate to severe OA of the knee.

Exclusion Criteria

• Abnormal anatomy of tibia or presence of pathology other than OA, e.g. bone tumour.
• Previous knee or osteotomy surgery.
• Presence of metal-work

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Devon and Exeter NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Bath

OTHER

Sponsor Role: lead

Responsible Party

Richie Gill

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richie Gill, DPhil

Role: PRINCIPAL_INVESTIGATOR

University of Bath

Andrew Toms, MD

Role: PRINCIPAL_INVESTIGATOR

Royal Devon & Exeter NHS Trust

Locations

Royal Devon & Exeter NHS Trust

Exeter, Devon, United Kingdom

University of Bath

Bath, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RG433_TVT003

Identifier Type: -

Identifier Source: org_study_id