Wrist Ligament and Bone DisordersNCT04736537
A Study to Evaluate 4DCT Controls
A study testing 4DCT in people with Wrist Ligament and Bone Disorders, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrist Ligament and Bone Disorders
- What is being tested?
- 4DCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2022to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ≥ 18 and ≤ 60 years.
- Control subjects without any history of wrist injury or disease.
- Exclusion Criteria (applied to both wrists for control subjects):
- Previously-diagnosed rheumatological conditions or connective tissue diseases;
- Inability to be appropriately positioned in the scanner for the imaging;
- Congenital malformations of the wrist or forearm;
- Diagnosed wrist osteoarthritis
- Age under 18 or over 60.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 4DCT Wrist Biomarkers During Resisted and Unresisted Tasks in Healthy Controls
The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit.
- Conditions
- Wrist Ligament and Bone Disorders
- Being tested
- 4DCT
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4DCTDevice
CT imaging conceptually similar to time-lapse photography.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Experimental | Not described Receives: Device: 4DCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scapholunate (SL) Gapping
Normalized volar/dorsal location of the gapping at the scapholunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Measured: Baseline
Radioscaphoid (RS) Gapping
Normalized volar/dorsal location of the gapping at the radioscaphoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Measured: Baseline
Radiolunate (RL) Gapping
Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Measured: Baseline
Secondary outcomes (3)
Scaphotrapezium (STm) Gapping
Normalized volar/dorsal location of the gapping at the scaphotrapezium joint, measured in millimeters, at each of the 17 time steps during each movement.
Measured: Baseline
Scaphotrapezoid (STd) Gapping
Normalized volar/dorsal location of the gapping at the scaphotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Measured: Baseline
Trapezoitrapezoid (TmTd) Gapping
Normalized volar/dorsal location of the gapping at the trapeziotrapezoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2021
- Study start4 Aug 2022
- Primary completion6 Apr 2023
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wrist Ligament and Bone DisordersStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Kristin Zhao, PhD, Mayo Clinic
- Investigators
- Kristin D. Zhao, Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04736537
- Sponsor's protocol ID
- 20-007668
- Other IDs
- R01AR071338
- Status last verified
- May 2024
- First submitted
- 11 Jan 2021
- Last updated
- 2 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4DCT Wrist Biomarkers During Resisted and Unresisted Tasks in Healthy Controls
- ClinicalTrials.gov ID
- NCT04736537
- Acronym / sponsor ID
- 20-007668
- Conditions
- Wrist Ligament and Bone Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 3 Feb 2021 (actual)
- Results
- Posted 2 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to use CT motion pictures (4DCT) to visualize and record how much space there is between certain wrist joint bones, both without any resistance and with light resistance to the movement, during a single scanning visit.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Controls | Experimental | Device: 4DCT |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age ≥ 18 and ≤ 60 years.
- Control subjects without any history of wrist injury or disease.
- Previously-diagnosed rheumatological conditions or connective tissue diseases;
- Inability to be appropriately positioned in the scanner for the imaging;
- Congenital malformations of the wrist or forearm;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| 4DCTCT imaging conceptually similar to time-lapse photography. | Device | Healthy Controls |
Primary outcome
Scapholunate (SL) Gapping
Time frame: Baseline
Normalized volar/dorsal location of the gapping at the scapholunate joint, measured in millimeters, at each of the 17 time steps during each movement.
Radioscaphoid (RS) Gapping
Time frame: Baseline
Normalized volar/dorsal location of the gapping at the radioscaphoid joint, measured in millimeters, at each of the 17 time steps during each movement.
Radiolunate (RL) Gapping
Time frame: Baseline
Normalized volar/dorsal location of the gapping at the radiolunate joint, measured in millimeters, at each of the 17 time steps during each movement.
3 secondary outcomes
Scaphotrapezium (STm) Gapping
Time frame: Baseline
Scaphotrapezoid (STd) Gapping
Time frame: Baseline
Trapezoitrapezoid (TmTd) Gapping
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Wrist Ligament and Bone Disorders
RecruitingObservational study
Registry of Arthrex Hand and Wrist Products
Ulnar/Radial Collateral Ligament Reconstruction, Ligament Repair or Reconstruction
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.
Kristin D. Zhao, Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4DCT in people with Wrist Ligament and Bone Disorders, run by Mayo Clinic at 1 site in United States.
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 8 inclusion and 0 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 2 May 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 2 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Scapholunate (SL) Gapping (time frame: Baseline). 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?
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 2 May 2024.