Post-traumatic; ArthrosisNCT04875156
The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength
A study testing measurement of range of motion and strength in people with Post-traumatic; Arthrosis and Osteoarthritis Thumb, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic; Arthrosis, Osteoarthritis Thumb
- What is being tested?
- measurement of range of motion and strength
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Sep 2020to 17 Apr 2021
- Phase
- Interventional
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 40 years
Who cannot join
- (previous) pathology of the joints, ligaments or tendons of the thumb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength: Implications for Arthrodesis
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.
Read the detailed description
The aim of the study is to measure the position of the metacarpophalangeal (MCP) joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.
The force will be measured in three positions (key-pinch, tripod-pinch and opposition-pinch). Also measured is the degree of flexion of the MCP joint of the thumb. The mobility of the MCP joint of the thumb in maximum flexion and extension will also be measured. A total of about 300 healthy volunteers will be examined, with no history of trauma or disease to tendons or joints of the thumbs and between the ages of 18 and 40. The sponsor of this study is Professor Nadine Hollevoet. Master students of medicine from the faculty of medicine and health sciences will be part of the research team.
- Conditions
- Post-traumatic; Arthrosis, Osteoarthritis Thumb
- Being tested
- measurement of range of motion and strength
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of range of motion and strengthOther
measurement of range of motion (goniometer) and strength (dynamometer) of the metacarpophalangeal joint of the thumb
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: measurement of range of motion and strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
pinch strength of the thumb (in kilograms force)
pinch strength of the thumb in key-pinch, opposition-pinch and tripod-pinch
Measured: 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
Measured: 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
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2021
- Study start23 Sep 2020
- Primary completion17 Apr 2021
- Study completion17 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-traumatic; ArthrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- measurement of the joint mobility and the force of the thumb
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine I Hollevoet, Phd, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04875156
- Sponsor's protocol ID
- BC-08063
- Status last verified
- Jan 2023
- First submitted
- 13 Apr 2021
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37401127
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Angle of the Metacarpophalangeal Joint of the Thumb During Maximal Pinch Strength: Implications for Arthrodesis
- ClinicalTrials.gov ID
- NCT04875156
- Acronym / sponsor ID
- BC-08063
- Conditions
- Post-traumatic; Arthrosis, Osteoarthritis Thumb
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 23 Sep 2020 (actual)
- Primary completion
- 17 Apr 2021 (actual)
- Study completion
- 17 Apr 2021 (actual)
- First posted
- 6 May 2021 (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.
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.
Detailed description
The aim of the study is to measure the position of the metacarpophalangeal (MCP) joint of the thumb during key-pinch, tripod-pinch and opposition-pinch in normal volunteers, to determine the optimal position of metacarpophalangeal joint arthrodesis.
The force will be measured in three positions (key-pinch, tripod-pinch and opposition-pinch). Also measured is the degree of flexion of the MCP joint of the thumb. The mobility of the MCP joint of the thumb in maximum flexion and extension will also be measured. A total of about 300 healthy volunteers will be examined, with no history of trauma or disease to tendons or joints of the thumbs and between the ages of 18 and 40. The sponsor of this study is Professor Nadine Hollevoet. Master students of medicine from the faculty of medicine and health sciences will be part of the research team.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- measurement of the joint mobility and the force of the thumb
| Arm | Type | Receives |
|---|---|---|
| normal volunteers | Other | Other: measurement of range of motion and strengthnormal 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age between 18 and 40 years
Key exclusion criteria (1 listed)
- (previous) pathology of the joints, ligaments or tendons of the thumb
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of range of motion and strengthmeasurement of range of motion (goniometer) and strength (dynamometer) of the metacarpophalangeal joint of the thumb | Other | normal volunteers |
Primary outcome
pinch strength of the thumb (in kilograms force)
Time frame: 10 minutes
pinch strength of the thumb in key-pinch, opposition-pinch and tripod-pinch
the angle of the metacarpophalangeal joint of the thumb (in degrees)
Time frame: 10 minutes
the angle of the metacarpophalangeal joint of the thumb (in degrees) during maximal force in the three pinch positions
range of motion of the metacarpophalangeal joint of the thumb (in degrees)
Time frame: 10 minutes
range of motion of the metacarpophalangeal joint of the thumb (in degrees) measuring maximal flexion and maximal extension of the joint
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 6 Jan 2023.
- Derived from this study: PubMed 37401127Gryson 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.
- Individual participant dataSharing planned: No
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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.
Nadine I Hollevoet, Phd principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing measurement of range of motion and strength in people with Post-traumatic; Arthrosis and Osteoarthritis Thumb, run by University Hospital, Ghent at 1 site in Belgium.
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 1 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 6 Jan 2023. 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 Belgium. 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?
pinch strength of the thumb (in kilograms force) (time frame: 10 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04875156, which also lists 1 linked publication.
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 6 Jan 2023.