Patient Specific Computational Modeling Clinical Trial
Official title:
Development of Parametric Musculoskeletal Models to Investigate the Anatomy and the Function of the PIP
| Verified date | November 2018 |
| Source | University of Southampton |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | September 5, 2017 |
| Est. primary completion date | September 5, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | University Hospital Southampton | Southampton | Hampshire |
| Lead Sponsor | Collaborator |
|---|---|
| University of Southampton |
United Kingdom,
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Capturing hand kinematics using Vicon optical motion capture | Capture hand kinematics of 10 healthy volunteers | 3 years | |
| Primary | 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 | 3 years | |
| Primary | 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 | 3 years |