Osteoarthritis, KneeNCT03419598
Personalised HTO Versus Generic HTO Virtual Clinical Trial
An observational study of Osteoarthritis, Knee, run by University of Bath at 2 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Opening wedge high tibial osteotomy, Personalised subject specific custom HTO plate and Generic HTO plate
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 3 Jan 2017to 28 Jun 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population was recruited from waiting list of patients with knee OA
Who may be able to join
- Appropriate existing CT data of lower limb.
- Male or Female, aged 18 years or above.
- Diagnosed with moderate to severe OA of the knee.
Who cannot join
- Abnormal anatomy of tibia or presence of pathology other than OA, e.g. bone tumour.
- Previous knee or osteotomy surgery.
- Presence of metal-work
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University of Bath
Bath, BA2 7AY
Royal Devon & Exeter NHS Trust
Exeter, Devon, EX2 5DW
About this study
Official title: Personalised Subject Specific HTO Versus Generic HTO Virtual Clinical Trial
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.
Read the 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
- Being tested
- Opening wedge high tibial osteotomy, Personalised subject specific custom HTO plate, Generic HTO plate
- Keywords
- virtual clinical trial, high tibial osteotomy, 3D, computer simulation, finite element analysis, medial unicompartmental knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opening wedge high tibial osteotomyProcedure or surgery
Also called HTO
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 plateDevice
Also called Personalised plate
Subject specific custom plate for stabilizing an open wedge HTO
Generic HTO plateDevice
Also called Generic plate
Generic plate for stabilizing an open wedge HTO
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Opening wedge high tibial osteotomy; Device: Personalised subject specific custom HTO plate; Device: Generic HTO plate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Stress in Plate During Gait
Mechanical stress (Von Mises) calculated for functional loading using finite element analysis
Measured: 6 weeks simulated post-operation
Secondary outcomes (1)
Mechanical Strain in Bone Around Screws During Gait
Mechanical strain calculated for functional loading using finite element analysis, note strain is dimensionless and hence has no units
Measured: 6 weeks simulated post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start3 Jan 2017
- Primary completion28 Jun 2019
- Study completion28 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bath
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Responsible party
- Principal investigator, Richie Gill, University of Bath
- Investigators
- Richie Gill, DPhil, Principal investigator, University of BathAndrew Toms, MD, Principal investigator, Royal Devon & Exeter NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419598
- Sponsor's protocol ID
- RG433_TVT003
- Status last verified
- Nov 2020
- First submitted
- 26 Jan 2018
- Last updated
- 7 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Virtual cohort may be re-used for further studies, all virtual patients are anonymized
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalised Subject Specific HTO Versus Generic HTO Virtual Clinical Trial
- ClinicalTrials.gov ID
- NCT03419598
- Acronym / sponsor ID
- RG433_TVT003
- Conditions
- Osteoarthritis, Knee
- Keywords
- virtual clinical trial, high tibial osteotomy, 3D, computer simulation, finite element analysis, medial unicompartmental knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BathUniversity, hospital or other
- Collaborators
- Royal Devon and Exeter NHS Foundation Trust
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 28 Jun 2019 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 7 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study participants | – | Procedure: Opening wedge high tibial osteotomy, Device: Personalised subject specific custom HTO plate, Device: Generic HTO plateAll virtual participants who received a virtual opening wedge high tibial osteotomy. The baseline information was the individual CT-based geometry of tibia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population was recruited from waiting list of patients with knee OA
Key inclusion criteria (3 listed)
- Appropriate existing CT data of lower limb.
- Male or Female, aged 18 years or above.
- Diagnosed with moderate to severe OA of the knee.
Key exclusion criteria (3 listed)
- Abnormal anatomy of tibia or presence of pathology other than OA, e.g. bone tumour.
- Previous knee or osteotomy surgery.
- Presence of metal-work
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opening wedge high tibial osteotomyAlso: HTORealignment 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 | Procedure or surgery | All study participants |
| Personalised subject specific custom HTO plateAlso: Personalised plateSubject specific custom plate for stabilizing an open wedge HTO | Device | All study participants |
| Generic HTO plateAlso: Generic plateGeneric plate for stabilizing an open wedge HTO | Device | All study participants |
Primary outcome
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
1 secondary outcome
Mechanical Strain in Bone Around Screws During Gait
Time frame: 6 weeks simulated post-operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Virtual cohort may be re-used for further studies, all virtual patients are anonymized
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richie Gill, DPhil principal investigator
University of Bath
Andrew Toms, MD principal investigator
Royal Devon & Exeter NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by University of Bath at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Stress in Plate During Gait (time frame: 6 weeks simulated post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2020.