NCT07082075

Brief Summary

Background: The volar plate (VP) is a key stabilizer of the proximal interphalangeal joint (PIPJ), and its biomechanical behavior may be altered in individuals with joint hypermobility. Objective: This study aimed to evaluate the spatial dynamics of the VP and its relationship with the center of joint motion and flexor digitorum profundus (FDP) tendon in individuals with and without joint hyperlaxity using MRI. Methods: Thirty-two healthy volunteers (16 hyperlax, 16 controls) underwent MRI imaging of both index fingers at five flexion angles (0°, 30°, 60°, 90°, full flexion) and under passive and isometric loading conditions. Key parameters measured included distances from the joint center to VP attachments, VP-FDP tendon distance, and the length between VP ends.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 28, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Last Updated

July 24, 2025

Status Verified

May 1, 2025

Enrollment Period

2 months

First QC Date

May 28, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

volar platehypermobilitybiomechanics

Outcome Measures

Primary Outcomes (4)

  • The Distance Between the Center of Motion (CoM) and the VPLip and VPTip

    The distances between the center of motion (CoM) and the volar lip of the middle phalanx base (VPLip), and between the CoM and the proximal end of the volar plate at its attachment to the volar base of the proximal phalanx (VPTip), were measured using RadiAnt DICOM Viewer software (version 2024.1) in various PIPJ angles.

    baseline

  • The Distance Between VPLip and VPTip

    The distance between the volar lip of the middle phalanx base (VPLip), and the proximal end of the volar plate at its attachment to the volar base of the proximal phalanx (VPTip) measured using RadiAnt DICOM Viewer software (version 2024.1) in various PIPJ angles. The purpose of this measurement was to observe how the distance between the two ends of the volar plate changes with varying joint angles.

    baseline

  • The Distance Between Volar Plate (VP) and FDP Tendon

    The distance between the midpoint of the volar plate (VP) and the flexor digitorum profundus (FDP) tendon was measured using RadiAnt DICOM Viewer software (version 2024.1) at various proximal interphalangeal joint (PIPJ) angles. The purpose of this measurement was to observe how this distance changes across different flexion angles.

    baseline

  • Changes Observed During Grasping and Isometric Contraction

    Measurements at all flexion angles were conducted under two conditions: while passively grasping a cylindrical object (without force) and during isometric contraction (with force).

    baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy and hypermobility volunteers

You may qualify if:

  • between 18-65 years

You may not qualify if:

  • any history of acute or overuse injuries to the examined hand,
  • any prior surgical procedures on the examined upper extremity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 28, 2025

First Posted

July 24, 2025

Study Start

May 15, 2023

Primary Completion

July 15, 2023

Study Completion

May 15, 2024

Last Updated

July 24, 2025

Record last verified: 2025-05

Locations