- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03094962
Development of a Musculoskeletal Model of the PIP Joint
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hampshire
-
Southampton, Hampshire, United Kingdom, SO17 1BJ
- University Hospital Southampton
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Motion capture, MR scan, CT scan
All volunteers will go through the same data collection process
|
Capture kinematics of finger movements
Capture MR images of hand and fingers in three postures
Capture CT images of hand and fingers in three postures
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Capturing hand kinematics using Vicon optical motion capture
Time Frame: 3 years
|
Capture hand kinematics of 10 healthy volunteers
|
3 years
|
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
|
3 years
|
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
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christopher WG Phillips, PhD, University of Southampton
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PUNI1713
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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