N/A
N=30
Personalised HTO Versus Generic HTO Virtual Clinical Trial
Osteoarthritis, Knee
Bottom Line
View on ClinicalTrials.gov: NCT03419598 ↗Enrolled (actual)
30
Serious AEs
—
Results posted
Dec 2020
Primary outcome: Primary: Mechanical Stress in Plate During Gait — 108.3; 90.6 MPa
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Opening wedge high tibial osteotomy (Procedure); Personalised subject specific custom HTO plate (Device); Generic HTO plate (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Bath
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mechanical Stress in Plate During Gait |
108.3; 90.6 | — |
| SECONDARY Mechanical Strain in Bone Around Screws During Gait |
0.011; 0.011 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03419598). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.