NCT04875156

Brief Summary

The aim of the study is to measure the position of the metacarpophalangeal joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 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

September 23, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

May 6, 2021

Completed
Last Updated

January 6, 2023

Status Verified

January 1, 2023

Enrollment Period

7 months

First QC Date

April 13, 2021

Last Update Submit

January 4, 2023

Conditions

Post-traumatic; ArthrosisOsteoarthritis Thumb

Outcome Measures

Primary Outcomes (3)

  • pinch strength of the thumb (in kilograms force)

    pinch strength of the thumb in key-pinch, opposition-pinch and tripod-pinch

    10 minutes

  • the angle of the metacarpophalangeal joint of the thumb (in degrees)

    the angle of the metacarpophalangeal joint of the thumb (in degrees) during maximal force in the three pinch positions

    10 minutes

  • range of motion of the metacarpophalangeal joint of the thumb (in degrees)

    range of motion of the metacarpophalangeal joint of the thumb (in degrees) measuring maximal flexion and maximal extension of the joint

    10 minutes

Study Arms (1)

normal volunteers

OTHER

normal volunteers between 18 and 40 years old, men and women. Measurement of the range of motion of the metacarpophalangeal joint with a goniometer and pinch strength of the thumb with a dynamometer

Other: measurement of range of motion and strength

Interventions

measurement of range of motion and strengthOTHER

measurement of range of motion (goniometer) and strength (dynamometer) of the metacarpophalangeal joint of the thumb

normal volunteers

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 40 years

You may not qualify if:

  • (previous) pathology of the joints, ligaments or tendons of the thumb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University Hospital

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

Related Publications (1)

  • Gryson T, Van Der Velde G, Hollevoet N. Metacarpophalangeal joint angle of the thumb during maximal pinch strength: a study of healthy volunteers. J Hand Surg Eur Vol. 2023 Dec;48(11):1229-1230. doi: 10.1177/17531934231184821. Epub 2023 Jul 3.

    PMID: 37401127DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Nadine I Hollevoet, Phd

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: measurement of the joint mobility and the force of the thumb
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

May 6, 2021

Study Start

September 23, 2020

Primary Completion

April 17, 2021

Study Completion

April 17, 2021

Last Updated

January 6, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)