Completed

NCT Number: NCT03094962

Development of a Musculoskeletal Model of the PIP Joint

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.

Completed

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Key information

Conditions

Patient Specific Computational Modeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Motion capture

Other

Capture kinematics of finger movements

MR scan

Diagnostic Test

Capture MR images of hand and fingers in three postures

CT Scan

Diagnostic Test

Capture CT images of hand and fingers in three postures

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Registry information

Official study title

Development of Parametric Musculoskeletal Models to Investigate the Anatomy and the Function of the PIP

Important dates

Study start: 2015
Primary completion: 2017
Study completion: 2017
First posted: Mar 29, 2017
Registry last updated: Nov 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.