Hypermobility, JointNCT07082075
Joint Hyperlaxity and Volar Plate Dynamics: MRI-Based Comparative Evaluation of the PIP Joint
An observational study of Hypermobility, Joint, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypermobility, Joint
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 May 2023to 15 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and hypermobility volunteers
Who may be able to join
- between 18-65 years
Who cannot join
- any history of acute or overuse injuries to the examined hand,
- any prior surgical procedures on the examined upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypermobility, Joint
- Keywords
- volar plate, hypermobility, biomechanics
- Medical subject headings
- Joint Instability
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start15 May 2023
- Primary completion15 Jul 2023
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility, JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University Ankara Hospital
- Responsible party
- Principal investigator, Cigdem Ayhan, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082075
- Sponsor's protocol ID
- KA22/286
- Status last verified
- May 2025
- First submitted
- 28 May 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It can not be ethical.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Joint Hyperlaxity and Volar Plate Dynamics: MRI-Based Comparative Evaluation of the PIP Joint
- ClinicalTrials.gov ID
- NCT07082075
- Acronym / sponsor ID
- KA22/286
- Conditions
- Hypermobility, Joint
- Keywords
- volar plate, hypermobility, biomechanics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Collaborators
- Baskent University Ankara Hospital
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and hypermobility volunteers
Key inclusion criteria (1 listed)
- between 18-65 years
Key exclusion criteria (2 listed)
- any history of acute or overuse injuries to the examined hand,
- any prior surgical procedures on the examined upper extremity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Distance Between the Center of Motion (CoM) and the VPLip and VPTip
Time frame: baseline
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.
The Distance Between VPLip and VPTip
Time frame: baseline
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.
The Distance Between Volar Plate (VP) and FDP Tendon
Time frame: baseline
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.
Changes Observed During Grasping and Isometric Contraction
Time frame: baseline
Measurements at all flexion angles were conducted under two conditions: while passively grasping a cylindrical object (without force) and during isometric contraction (with force).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Undecided. It can not be ethical.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobility, Joint, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Distance Between the Center of Motion (CoM) and the VPLip and VPTip (time frame: baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.