Patient Specific Computational ModelingNCT03094962
Development of a Musculoskeletal Model of the PIP Joint
A study testing Motion capture, MR scan and CT scan in people with Patient Specific Computational Modeling, run by University of Southampton at 1 site in United Kingdom.
Trial summary
The proximal interphalangeal (PIP) joint is the second joint in the finger from the finger tip. The outcome following replacement surgery of this joint is considered unsatisfactory. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Specific Computational Modeling
- What is being tested?
- Motion capture, MR scan and CT scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jan 2015to 5 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In general good health
- University of Southampton members of staff
- Over 18 years old and able to provide informed consent
- No known problems relating to the PIP joint
Who cannot join
- Volunteers involved in other studies concerned with the function and anatomy of the PIP joint which would have adverse effects on this study and/or the study in which they are currently involved.
- Those undergoing treatment related to the PIP joint
- No metallic object should be present in the scanner and therefore those with any implanted metallic devices, or other devices which may cause or be caused adverse effects (e.g. metal plate, pacemaker)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital Southampton
Southampton, Hampshire, SO17 1BJ
About this study
Official title: Development of Parametric Musculoskeletal Models to Investigate the Anatomy and the Function of the PIP
The proximal interphalangeal (PIP) joint is the second joint in the finger from the finger tip. The outcome following replacement surgery of this joint is considered unsatisfactory. In order to improve these outcomes, it would be helpful to understand the geometry of the joint, how it moves and the forces that are involved. This can be achieved using computer models that model the bones and the soft tissues - musculoskeletal models. In order to make these models as representative as possible, they should be generated using anatomical data.
Data will initially be extracted from patients' existing magnetic resonance imaging (MRI) and computed tomography (CT) scans. This will enable the computer model to begin being constructed. In parallel to the model initialisation, anatomical and motion data of the PIP joint of healthy volunteers will be collected. The necessary data will be collected using CT and MRI scans, as well as optical motion tracking methods. These data will then be used to populate the musculoskeletal model.
Once the model is constructed, it will be used to simulate the motion of the joint and look at the effect of a simulated PIP joint replacement. This information should then provide insight as to how PIP joint replacements might be improved in future.
- Conditions
- Patient Specific Computational Modeling
- Being tested
- Motion capture, MR scan, CT scan
- Keywords
- Kinematics, MRI Scans, CT Scan, Single-Photon Emission, finger interphalangeal joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion captureOther
Capture kinematics of finger movements
MR scanDiagnostic test
Capture MR images of hand and fingers in three postures
CT scanDiagnostic test
Capture CT images of hand and fingers in three postures
| Study group | Role | What they receive |
|---|---|---|
| Motion capture, MR scan, CT scan | Other | All volunteers will go through the same data collection process Receives: Other: Motion capture; Diagnostic Test: MR scan; Diagnostic Test: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capturing hand kinematics using Vicon optical motion capture
Capture hand kinematics of 10 healthy volunteers
Measured: 3 years
Capturing images of the soft tissue in the hand using MR imaging
Capture MR images of the hand for same 10 healthy volunteers as Outcome 1
Measured: 3 years
Capturing images of the bony structures in the hand using CT scanning
Capture CT images of the hand for same 10 healthy volunteers as Outcome 1
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2017
- Study start21 Jan 2015
- Primary completion5 Sep 2017
- Study completion5 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Specific Computational ModelingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher WG Phillips, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03094962
- Sponsor's protocol ID
- PUNI1713
- Status last verified
- Nov 2018
- First submitted
- 9 Mar 2017
- Last updated
- 15 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adams J, Ryall C, Pandyan A, Metcalf C, Stokes M, Bradley S, Warwick DJ. Proximal interphalangeal joint replacement in patients with arthritis of the hand: a meta-analysis. J Bone Joint Surg Br. 2012 Oct;94(10):1305-12. doi: 10.1302/0301-620X.94B10.29035.
PubMed 23015553
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Parametric Musculoskeletal Models to Investigate the Anatomy and the Function of the PIP
- ClinicalTrials.gov ID
- NCT03094962
- Acronym / sponsor ID
- PUNI1713
- Conditions
- Patient Specific Computational Modeling
- Keywords
- Kinematics, MRI Scans, CT Scan, Single-Photon Emission, finger interphalangeal joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Study start
- 21 Jan 2015 (actual)
- Primary completion
- 5 Sep 2017 (actual)
- Study completion
- 5 Sep 2017 (actual)
- First posted
- 29 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proximal interphalangeal (PIP) joint is the second joint in the finger from the finger tip. The outcome following replacement surgery of this joint is considered unsatisfactory. In order to improve these outcomes, it would be helpful to understand the geometry of the joint, how it moves and the forces that are involved. This can be achieved using computer models that model the bones and the soft tissues - musculoskeletal models. In order to make these models as representative as possible, they should be generated using anatomical data.
Data will initially be extracted from patients' existing magnetic resonance imaging (MRI) and computed tomography (CT) scans. This will enable the computer model to begin being constructed. In parallel to the model initialisation, anatomical and motion data of the PIP joint of healthy volunteers will be collected. The necessary data will be collected using CT and MRI scans, as well as optical motion tracking methods. These data will then be used to populate the musculoskeletal model.
Once the model is constructed, it will be used to simulate the motion of the joint and look at the effect of a simulated PIP joint replacement. This information should then provide insight as to how PIP joint replacements might be improved in future.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motion capture, MR scan, CT scan | Other | Other: Motion capture, Diagnostic Test: MR scan, Diagnostic Test: CT scanAll volunteers will go through the same data collection process |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In general good health
- University of Southampton members of staff
- Over 18 years old and able to provide informed consent
- No known problems relating to the PIP joint
Key exclusion criteria (3 listed)
- Volunteers involved in other studies concerned with the function and anatomy of the PIP joint which would have adverse effects on this study and/or the study in which they are currently involved.
- Those undergoing treatment related to the PIP joint
- No metallic object should be present in the scanner and therefore those with any implanted metallic devices, or other devices which may cause or be caused adverse effects (e.g. metal plate, pacemaker)
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 |
|---|---|---|
| Motion captureCapture kinematics of finger movements | Other | Motion capture, MR scan, CT scan |
| MR scanCapture MR images of hand and fingers in three postures | Diagnostic test | Motion capture, MR scan, CT scan |
| CT scanCapture CT images of hand and fingers in three postures | Diagnostic test | Motion capture, MR scan, CT scan |
Primary outcome
Capturing hand kinematics using Vicon optical motion capture
Time frame: 3 years
Capture hand kinematics of 10 healthy volunteers
Capturing images of the soft tissue in the hand using MR imaging
Time frame: 3 years
Capture MR images of the hand for same 10 healthy volunteers as Outcome 1
Capturing images of the bony structures in the hand using CT scanning
Time frame: 3 years
Capture CT images of the hand for same 10 healthy volunteers as Outcome 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Background: PubMed 23015553Adams J, Ryall C, Pandyan A, Metcalf C, Stokes M, Bradley S, Warwick DJ. Proximal interphalangeal joint replacement in patients with arthritis of the hand: a meta-analysis. J Bone Joint Surg Br. 2012 Oct;94(10):1305-12. doi: 10.1302/0301-620X.94B10.29035.
- Individual participant dataSharing planned: No
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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.
Christopher WG Phillips, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motion capture, MR scan and CT scan in people with Patient Specific Computational Modeling, run by University of Southampton at 1 site 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 4 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 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Capturing hand kinematics using Vicon optical motion capture (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03094962, which also lists 1 linked publication.
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 15 Nov 2018.