Basilar Thumb ArthritisNCT05753891
Trapeziectomy: Internal Brace vs. Ligament Reconstruction (Prospective)
A study testing Suture Tape Reconstruction in people with Basilar Thumb Arthritis, run by Henry Ford Health System at 1 site in United States.
Trial summary
This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon interposition, which means removing the trapezium bone and filling the void with a tendon graft. This is the most commonly used procedure and the control group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basilar Thumb Arthritis
- What is being tested?
- Suture Tape Reconstruction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 3 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of Henry Ford Orthopedic Service Line
- Symptomatic basilar thumb arthritis refractory to conservative management
Who cannot join
- Significant medical comorbidity precluding safe surgery, as determined by the operating surgeon. This may include cardiac disease, renal disease, liver disease, pulmonary disease, or heavy substance abuse.
- Requirement for additional procedures at the 1st carpometacarpal joint, including trapezoid excision-whole or partial-or metacarpal osteotomy. Of note other existing conditions requiring intervention on a separate surgical site such as concomitant carpal tunnel syndrome or trigger fingers will NOT be used as exclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study
This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon interposition, which means removing the trapezium bone and filling the void with a tendon graft. This is the most commonly used procedure and the control group. The experimental group is trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal. This is using a device called the InternalBrace, produced by Arthrex.
- Conditions
- Basilar Thumb Arthritis
- Being tested
- Suture Tape Reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suture Tape ReconstructionDevice
Also called Arthrex InternalBrace
This intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition.
| Study group | Role | What they receive |
|---|---|---|
| Carpometacarpal (CMC) Suture Tape Ligament Reconstruction | Experimental | Patients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group. Receives: Device: Suture Tape Reconstruction |
| Carpometacarpal (CMC) Standard Ligament Reconstruction | No intervention | Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pinch Strength
Pinch Strength measurements
Measured: 6 months post procedure
Secondary outcomes (1)
PROMIS-UE
PROMIS-UE scores are reported as T-scores standardized to the U.S. population (mean 50, SD 10; typical range ~15-61). Higher scores indicate better upper extremity function.
Measured: 6 months post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Apr 2023
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Why it stopped: Under-enrollment, was not feasible to be completed with a satisfactory sample size.
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 Basilar Thumb ArthritisStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles S Day, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753891
- Sponsor's protocol ID
- 16162
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2023
- Last updated
- 17 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapeziectomy With Internal Brace Versus Ligament Reconstruction With Tendon Interposition; a Prospective Study
- ClinicalTrials.gov ID
- NCT05753891
- Acronym / sponsor ID
- 16162
- Conditions
- Basilar Thumb Arthritis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Under-enrollment, was not feasible to be completed with a satisfactory sample size.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 3 Mar 2023 (actual)
- Results
- Posted 17 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to compare two methods of trapeziectomy for basilar thumb arthritis. The first is trapeziectomy with ligament reconstruction and tendon interposition, which means removing the trapezium bone and filling the void with a tendon graft. This is the most commonly used procedure and the control group. The experimental group is trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal. This is using a device called the InternalBrace, produced by Arthrex.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carpometacarpal (CMC) Suture Tape Ligament Reconstruction | Experimental | Device: Suture Tape ReconstructionPatients in this arm will undergo trapeziectomy with suture tape suspension of the 1st metacarpal to the 2nd metacarpal via Arthrex InternalBrace device. This is the experimental group. |
| Carpometacarpal (CMC) Standard Ligament Reconstruction | No intervention | –Patients in this arm are considered the control group and will undergo trapeziectomy with ligament reconstruction and tendon interposition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients of Henry Ford Orthopedic Service Line
- Symptomatic basilar thumb arthritis refractory to conservative management
Key exclusion criteria (2 listed)
- Significant medical comorbidity precluding safe surgery, as determined by the operating surgeon. This may include cardiac disease, renal disease, liver disease, pulmonary disease, or heavy substance abuse.
- Requirement for additional procedures at the 1st carpometacarpal joint, including trapezoid excision-whole or partial-or metacarpal osteotomy. Of note other existing conditions requiring intervention on a separate surgical site such as concomitant carpal tunnel syndrome or trigger fingers will NOT be used as exclusion criteria.
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 |
|---|---|---|
| Suture Tape ReconstructionAlso: Arthrex InternalBraceThis intervention will utilize a suture tape to suspend the 1st and 2nd metacarpal post trapeziectomy compared to the standard procedure of a trapeziectomy followed by ligament reconstruction and tendon interposition. | Device | Carpometacarpal (CMC) Suture Tape Ligament Reconstruction |
Primary outcome
Pinch Strength
Time frame: 6 months post procedure
Pinch Strength measurements
1 secondary outcome
PROMIS-UE
Time frame: 6 months post procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Basilar Thumb Arthritis
RecruitingPhase 3
NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis
Thumb Osteoarthritis
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?
A study testing Suture Tape Reconstruction in people with Basilar Thumb Arthritis, run by Henry Ford Health System 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 2 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: stopped early, as of the sponsor's last update on 17 Apr 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?
Yes. Results are posted in the registry (first posted 17 Apr 2026). 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?
Pinch Strength (time frame: 6 months post procedure). 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 17 Apr 2026.