Hypermobility of Interphalangeal JointsNCT05903391
Splint Users' Satisfaction and Functional Status With Custom Finger Splints
A study testing 3D-Printed Finger Splints and Conventional Finger Splints in people with Hypermobility of Interphalangeal Joints and Swan-Neck Deformity, run by Endeavor Health at 2 sites in United States.
Trial summary
This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypermobility of Interphalangeal Joints, Swan-Neck Deformity
- What is being tested?
- 3D-Printed Finger Splints and Conventional Finger Splints
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2023to 17 Feb 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fluent in English
- 18 years or older
- Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-neck deformity)
- Pregnant or not pregnant women
- Able to tolerate a finger orthosis over the course of 1 month
- Not decisionally impaired
- Have or have not previously worn a finger orthosis for symptoms
Who cannot join
- Non-fluent in English
- Decisionally impaired
- Younger than 18 years old
- No proximal interphalangeal joint (PIP) joint finger hyperextension
- Unable to tolerate a finger orthosis over the course of 1 month
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Swedish Hospital Part of NorthShore University HealthSystems
Chicago, Illinois, 60625
NorthShore University HealthSystem
Evanston, Illinois, 60201
About this study
Official title: Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study
This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3D-printed finger splint) or a control group (conventional thermoplastic finger splint). Participants will wear assigned splint for 1 month. Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. It will further justify the need for the application of 3D-printing in a clinical setting.
- Being tested
- 3D-Printed Finger Splints, Conventional Finger Splints
- Keywords
- 3d-printing, technology, finger splints, hypermobile joints
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Printed Finger SplintsDevice
The intervention is wearing a novel finger splint produced by a 3D-printer
Conventional Finger SplintsDevice
This intervention is wearing a finger splint produced by a conventional method using thermoplastic material typically used in a clinical setting
| Study group | Role | What they receive |
|---|---|---|
| 3D-Printed Finger Splints | Experimental | Participants who wear the experimental customizable 3D-printed finger splints Receives: Device: 3D-Printed Finger Splints |
| Conventional Finger Splints | Active comparator | Participants who wear the control, conventionally made finger splints Receives: Device: Conventional Finger Splints |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
A modified version of a Self-report questionnaire which measures participants satisfaction with assigned splint device
Measured: 1 month
Modified Version of Orthotics and Prosthetics User Survey - Functional Status
A modified version of a Self-report questionnaire which measures participants' functional status during the duration of time wearing assigned finger splint device
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start9 Nov 2023
- Primary completion17 Feb 2025
- Study completion17 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypermobility of Interphalangeal JointsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Irani, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05903391
- Sponsor's protocol ID
- EH23-047
- Status last verified
- Mar 2025
- First submitted
- 5 Jun 2023
- Last updated
- 27 Mar 2025
- Results posted
- 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 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Splint Users' Satisfaction and Functional Status With Custom Finger Splints: A Feasibility and Comparison Study
- ClinicalTrials.gov ID
- NCT05903391
- Acronym / sponsor ID
- EH23-047
- Keywords
- 3d-printing, technology, finger splints, hypermobile joints
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 17 Feb 2025 (actual)
- Study completion
- 17 Feb 2025 (actual)
- First posted
- 15 Jun 2023 (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.
This feasibility and non-randomized comparison study explores the possible benefits of splint design and production by 3D-printing in a clinical setting and looks at splint users' experiences with customizable 3D-printed finger splints compared to conventionally made splints. Fifty participants with a hyperextended finger condition are assigned by researcher to either an interventional group (customizable 3D-printed finger splint) or a control group (conventional thermoplastic finger splint). Participants will wear assigned splint for 1 month. Functional status and satisfaction with splint will be assessed at the end of the 1-month duration in the form of surveys on satisfaction and functional status participants will be asked to complete. The findings will contribute to evidence that customizable 3D-printed finger splints can serve as a feasible, cost-effective option to improve patient satisfaction and functional status. It will further justify the need for the application of 3D-printing in a clinical setting.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D-Printed Finger Splints | Experimental | Device: 3D-Printed Finger SplintsParticipants who wear the experimental customizable 3D-printed finger splints |
| Conventional Finger Splints | Active comparator | Device: Conventional Finger SplintsParticipants who wear the control, conventionally made finger splints |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fluent in English
- 18 years or older
- Finger proximal interphalangeal joint (PIP) joint hyperextension (with or without swan-neck deformity)
- Pregnant or not pregnant women
- Able to tolerate a finger orthosis over the course of 1 month
Key exclusion criteria (5 listed)
- Non-fluent in English
- Decisionally impaired
- Younger than 18 years old
- No proximal interphalangeal joint (PIP) joint finger hyperextension
- Unable to tolerate a finger orthosis over the course of 1 month
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 |
|---|---|---|
| 3D-Printed Finger SplintsThe intervention is wearing a novel finger splint produced by a 3D-printer | Device | 3D-Printed Finger Splints |
| Conventional Finger SplintsThis intervention is wearing a finger splint produced by a conventional method using thermoplastic material typically used in a clinical setting | Device | Conventional Finger Splints |
Primary outcome
Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device
Time frame: 1 month
A modified version of a Self-report questionnaire which measures participants satisfaction with assigned splint device
Modified Version of Orthotics and Prosthetics User Survey - Functional Status
Time frame: 1 month
A modified version of a Self-report questionnaire which measures participants' functional status during the duration of time wearing assigned finger splint device
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 27 Mar 2025.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Printed Finger Splints and Conventional Finger Splints in people with Hypermobility of Interphalangeal Joints and Swan-Neck Deformity, run by Endeavor Health at 2 sites 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 7 inclusion and 5 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 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Modified Version of Orthotics and Prosthetics User Survey - Satisfaction with Device (time frame: 1 month). The study lists 2 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 27 Mar 2025.