Personalised HTO Versus Generic HTO Virtual Clinical Trial
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ClinicalTrials.gov Identifier: NCT03419598 |
Recruitment Status :
Completed
First Posted : February 5, 2018
Results First Posted : December 7, 2020
Last Update Posted : December 7, 2020
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Tracking Information | |||||||
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First Submitted Date | January 26, 2018 | ||||||
First Posted Date | February 5, 2018 | ||||||
Results First Submitted Date | October 5, 2019 | ||||||
Results First Posted Date | December 7, 2020 | ||||||
Last Update Posted Date | December 7, 2020 | ||||||
Actual Study Start Date | January 3, 2017 | ||||||
Actual Primary Completion Date | June 28, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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
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Original Primary Outcome Measures |
Mechanical stress in plate [ Time Frame: 6 weeks simulated post-operation ] Mechanical strain calculated for functional loading using finite element analysis
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Change History | |||||||
Current Secondary Outcome Measures |
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
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Original Secondary Outcome Measures |
Mechanical strain in bone around screws [ Time Frame: 6 weeks simulated post-operation ] Mechanical strain calculated for functional loading using finite element analysis
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title | Personalised HTO Versus Generic HTO Virtual Clinical Trial | ||||||
Official Title | Personalised Subject Specific HTO Versus Generic HTO Virtual Clinical Trial | ||||||
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. |
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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. |
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Study Type | Observational | ||||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
Sampling Method | Non-Probability Sample | ||||||
Study Population | Population was recruited from waiting list of patients with knee OA | ||||||
Condition | Osteoarthritis, Knee | ||||||
Intervention |
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Study Groups/Cohorts | 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.
Interventions:
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
30 | ||||||
Original Estimated Enrollment |
20 | ||||||
Actual Study Completion Date | June 28, 2019 | ||||||
Actual Primary Completion Date | June 28, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United Kingdom | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT03419598 | ||||||
Other Study ID Numbers | RG433_TVT003 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Richie Gill, University of Bath | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | University of Bath | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators | Royal Devon and Exeter NHS Foundation Trust | ||||||
Investigators |
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PRS Account | University of Bath | ||||||
Verification Date | November 2020 |