Personalised HTO Versus Generic HTO Virtual Clinical Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03419598|
Recruitment Status : Completed
First Posted : February 5, 2018
Results First Posted : December 7, 2020
Last Update Posted : December 7, 2020
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.
|Condition or disease||Intervention/treatment|
|Osteoarthritis, Knee||Procedure: Opening wedge high tibial osteotomy Device: Personalised subject specific custom HTO plate Device: Generic HTO plate|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Personalised Subject Specific HTO Versus Generic HTO Virtual Clinical Trial|
|Actual Study Start Date :||January 3, 2017|
|Actual Primary Completion Date :||June 28, 2019|
|Actual Study Completion Date :||June 28, 2019|
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
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
Other Name: HTO
Device: Personalised subject specific custom HTO plate
Subject specific custom plate for stabilizing an open wedge HTO
Other Name: Personalised plate
Device: Generic HTO plate
Generic plate for stabilizing an open wedge HTO
Other Name: Generic plate
- Mechanical Stress in Plate During Gait [ Time Frame: 6 weeks simulated post-operation ]Mechanical stress (Von Mises) calculated for functional loading using finite element analysis
- Mechanical Strain in Bone Around Screws During Gait [ Time Frame: 6 weeks simulated post-operation ]Mechanical strain calculated for functional loading using finite element analysis, note strain is dimensionless and hence has no units
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03419598
|Royal Devon & Exeter NHS Trust|
|Exeter, Devon, United Kingdom, EX2 5DW|
|University of Bath|
|Bath, United Kingdom, BA2 7AY|
|Principal Investigator:||Richie Gill, DPhil||University of Bath|
|Principal Investigator:||Andrew Toms, MD||Royal Devon & Exeter NHS Trust|