Personalised HTO Versus Generic HTO Virtual Clinical Trial

NCT03419598 | Completed Results

• 1 other identifier: RG433_TVT003
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Osteoarthritis, Knee

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Mechanical Stress in Plate During Gait

  Mechanical stress (Von Mises) calculated for functional loading using finite element analysis

  6 weeks simulated post-operation

Secondary Outcomes (1)

• Mechanical Strain in Bone Around Screws During Gait

  6 weeks simulated post-operation

Study Arms (1)

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.

Procedure: Opening wedge high tibial osteotomy; Device: Personalised subject specific custom HTO plate; Device: Generic HTO plate

Interventions

Opening wedge high tibial osteotomy 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

Also known as: HTO

All study participants

Personalised subject specific custom HTO plate DEVICE

Subject specific custom plate for stabilizing an open wedge HTO

Also known as: Personalised plate

All study participants

Generic HTO plate DEVICE

Generic plate for stabilizing an open wedge HTO

Also known as: Generic plate

All study participants

Eligibility Criteria

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

Study Population

Population was recruited from waiting list of patients with knee OA

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bath: lead
• Royal Devon and Exeter NHS Foundation Trust: collaborator

Study Sites (2)

Royal Devon & Exeter NHS Trust

Exeter, Devon, EX2 5DW, United Kingdom

Location

University of Bath

Bath, BA2 7AY, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

The main failure mode of HTO plates is fatigue failure, if the peak stress is below the fatigue limit the risk of fatigue failure is low.

Results Point of Contact

• Title: Professor Richie Gill
• Organization: University of Bath

r.gill@bath.ac.uk

01225 383627

Study Officials

• Richie Gill, DPhil

  University of Bath

  PRINCIPAL INVESTIGATOR

• Andrew Toms, MD

  Royal Devon & Exeter NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 5, 2018
• Study Start: January 3, 2017
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: December 7, 2020
• Results First Posted: December 7, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)