Carpometacarpal (CMC) Joint ArthritisWoodcastNCT06876350
Woodcasting Versus Thermoplast Splint in CMC Arthroplasty
A study testing Woodcasting Splint in people with Carpometacarpal (CMC) Joint Arthritis, run by Foundation for Orthopaedic Research and Education at 1 site in United States.
Trial summary
This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpometacarpal (CMC) Joint Arthritis
- What is being tested?
- Woodcasting Splint
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2024to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients over the age of 18 years old.
- Intact Medical Decision Making
- Eligible for Surgical Intervention
- Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks
Who cannot join
- Pregnant Women
- Deemed Unsuitable by Principal Investigator
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida Orthopaedic Institute
Tampa, Florida, 33637
Andy Nguyen, BS, 8139789700 ext. 6837, anguyen@foreonline.org
Michael Doarn, MD
About this study
Official title: Patient Satisfaction for Post-Operative Carpometacarpal Arthroplasty: Wood Casting Versus Thermoplastic Splint
This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.
Read the detailed description
Patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.
- Conditions
- Carpometacarpal (CMC) Joint Arthritis
- Being tested
- Woodcasting Splint, Control (Standard treatment)
- Keywords
- Randomized, Hand and Upper Extremity
- Medical subject headings
- Capillary Malformations, Congenital, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Woodcasting SplintOther
This is the experimental group so we could see the outcomes and preference for patients using surveys and compliance scores
Control (Standard treatment)Other
Thermoplastic splints are standard of care treatment for patients after CMC arthroplasty. We will use the data from this group as the comparator to the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Woodcasting Splint | Experimental | Woodcasting is an already FDA approved on the market product that is not used a lot so for the purpose of the study we would like to show superior outcomes. Receives: Other: Woodcasting Splint |
| Thermoplastic Splint | Active comparator | Thermoplastic splints is an FDA approved on the market orthrosis that is used by Occupational Therapists which is standard of care for patients that undergo CMC arthroplasty. Receives: Other: Control (Standard treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction Score
The satisfaction survey consists of three questions totaling 15. The minimum value is a 1, while the maximum value is 15. A higher score indicating highest satisfaction.
Measured: 6 Weeks
Secondary outcomes (3)
Waste
Each splint group creates waste for the fabrication and molding for each patient which will be recorded by the clinical research coordinator and weighed out.
Measured: 2 Weeks
Splint Satisfaction
Patient will have three questions totaling 15 with the higher score indicating highest satisfaction.
Measured: 6 Weeks
Splint Issues
A single question will be filled out by patients on a scale of 1-5 with a score of 5 indicating a lot of issues with their splint.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start3 Oct 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
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 Carpometacarpal (CMC) Joint ArthritisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation for Orthopaedic Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael C. Doarn, Foundation for Orthopaedic Research and Education
- Investigators
- Michael Doarn, MD, Principal investigator, Florida Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06876350
- Sponsor's protocol ID
- Study007574
- Acronym
- Woodcast
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Each participant data will be grouped for each cohort and averaged, so individual participant data is not necessary to perform a data analysis of the study.
Publications
Nguyen T, Hung VT, Hancock JU, Bailey D, Hess AV, Doarn M. Evaluating Patient Compliance With Woodcast and Thermoplast Splints After Thumb Carpometacarpal Arthroplasty: A Randomized Controlled Trial. Hand (N Y). 2026 Feb 8:15589447251415394. doi: 10.1177/15589447251415394. Online ahead of print.
PubMed 41656908
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction for Post-Operative Carpometacarpal Arthroplasty: Wood Casting Versus Thermoplastic Splint
- ClinicalTrials.gov ID
- NCT06876350
- Acronym / sponsor ID
- Woodcast / Study007574
- Conditions
- Carpometacarpal (CMC) Joint Arthritis
- Keywords
- Randomized, Hand and Upper Extremity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Foundation for Orthopaedic Research and EducationUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 14 Mar 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.
This study is a prospective, randomized, nonblinded trial to evaluate patient preference in splints after having a carpometacarpal arthroplasty.
Detailed description
Patients undergoing carpometacarpal arthroplasty will be randomized into the woodcast or thermoplast splint after their surgery to see which is preferred using compliance and surveys.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Woodcasting Splint | Experimental | Other: Woodcasting SplintWoodcasting is an already FDA approved on the market product that is not used a lot so for the purpose of the study we would like to show superior outcomes. |
| Thermoplastic Splint | Active comparator | Other: Control (Standard treatment)Thermoplastic splints is an FDA approved on the market orthrosis that is used by Occupational Therapists which is standard of care for patients that undergo CMC arthroplasty. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18 years old.
- Intact Medical Decision Making
- Eligible for Surgical Intervention
- Willing to comply with all aspects of the treatment and evaluation schedule over 6 weeks
Key exclusion criteria (2 listed)
- Pregnant Women
- Deemed Unsuitable by Principal Investigator
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 |
|---|---|---|
| Woodcasting SplintThis is the experimental group so we could see the outcomes and preference for patients using surveys and compliance scores | Other | Woodcasting Splint |
| Control (Standard treatment)Thermoplastic splints are standard of care treatment for patients after CMC arthroplasty. We will use the data from this group as the comparator to the experimental group. | Other | Thermoplastic Splint |
Primary outcome
Patient Satisfaction Score
Time frame: 6 Weeks
The satisfaction survey consists of three questions totaling 15. The minimum value is a 1, while the maximum value is 15. A higher score indicating highest satisfaction.
3 secondary outcomes
Waste
Time frame: 2 Weeks
Splint Satisfaction
Time frame: 6 Weeks
Splint Issues
Time frame: 6 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Derived from this study: PubMed 41656908Nguyen T, Hung VT, Hancock JU, Bailey D, Hess AV, Doarn M. Evaluating Patient Compliance With Woodcast and Thermoplast Splints After Thumb Carpometacarpal Arthroplasty: A Randomized Controlled Trial. Hand (N Y). 2026 Feb 8:15589447251415394. doi: 10.1177/15589447251415394. Online ahead of print.
- Individual participant dataSharing planned: No. Each participant data will be grouped for each cohort and averaged, so individual participant data is not necessary to perform a data analysis of the study.
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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.
Michael Doarn, MD principal investigator
Florida Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Woodcasting Splint in people with Carpometacarpal (CMC) Joint Arthritis, run by Foundation for Orthopaedic Research and Education 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 4 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andy Nguyen, BS (8139789700 ext. 6837, anguyen@foreonline.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Satisfaction Score (time frame: 6 Weeks). 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 NCT06876350, 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 25 Sep 2026.