NCT03094962

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2017

Completed
Last Updated

November 15, 2018

Status Verified

November 1, 2018

Enrollment Period

2.6 years

First QC Date

March 9, 2017

Last Update Submit

November 14, 2018

Conditions

Keywords

KinematicsMRI ScansCT Scan, Single-Photon Emissionfinger interphalangeal joint

Outcome Measures

Primary Outcomes (3)

  • Capturing hand kinematics using Vicon optical motion capture

    Capture hand kinematics of 10 healthy volunteers

    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

    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

    3 years

Study Arms (1)

Motion capture, MR scan, CT scan

OTHER

All volunteers will go through the same data collection process

Other: Motion captureDiagnostic Test: MR scanDiagnostic Test: CT scan

Interventions

Capture kinematics of finger movements

Motion capture, MR scan, CT scan
MR scanDIAGNOSTIC_TEST

Capture MR images of hand and fingers in three postures

Motion capture, MR scan, CT scan
CT scanDIAGNOSTIC_TEST

Capture CT images of hand and fingers in three postures

Motion capture, MR scan, CT scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 23015553BACKGROUND

MeSH Terms

Interventions

Motion CaptureTomography, X-Ray Computed

Intervention Hierarchy (Ancestors)

Diagnostic Tests, RoutineDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesImage Interpretation, Computer-AssistedDiagnostic ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayTomography

Study Officials

  • Christopher WG Phillips, PhD

    University of Southampton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 29, 2017

Study Start

January 21, 2015

Primary Completion

September 5, 2017

Study Completion

September 5, 2017

Last Updated

November 15, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations