Thumb OsteoarthritisTMCAINCT07148349
Artificial Intelligence in Trapeziometacarpal Joint Osteoarthritis: Improving Assessment and Clinical Decision-Making
An observational study of Thumb Osteoarthritis, run by Schulthess Klinik at 1 site in Switzerland.
Trial summary
This is a retrospective cohort study utilizing radiographic and computed tomography (CT) imaging data collected during routine clinical care at Schulthess Klinik Zürich. The study focuses on developing and validating artificial intelligence (AI)-based tools for the assessment of trapeziometacarpal (TMC) joint… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Thumb Osteoarthritis
- How many people
- 2,500 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2025to Aug 2028
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The study population consists of patients treated at Schulthess Klinik Zürich with available radiographic imaging of the TMC joint. Data are derived from two cohorts: (1) patients enrolled in the TMC arthroplasty registry (BASEC number: 2019-02096) who received a Touch implant since 2018, and (2) patients with other wrist-related conditions requiring radiographs in which the TMC joint is clearly visible. The combined cohorts provide a balanced representation across the spectrum of TMC joint OA severity, from healthy joints to end-stage disease.
Who may be able to join
- Patients will be included in the study if they have provided written general consent for the use of their clinical data and meet the requirements of one of the following two groups:
- TMC OA group:
- Patients who received a Touch implant for TMC joint arthroplasty and are documented in our clinical registry
- Other clinical conditions:
- Patients who underwent radiographic imaging for one of the following conditions, with a clearly visible TMC joint, for example: Distal radius fracture, carpal fracture, finger dislocation, or similar.
Who cannot join
- The exclusion criteria are defined based on the two inclusion groups:
- TMC OA group:
- Patients with posttraumatic OA.
- Patients with rheumatoid arthritis.
- Other clinical conditions:
- Eaton Littler score higher than one.
Show all 9Show fewer
- Prior surgery affecting the trapezium or the first metacarpal.
- Clinical condition resulting in abnormal TMC joint morphology.
- Furthermore, patients will also be excluded if they revoke their consent in writing or via verbal withdrawal.
Trial locations and contacts
1 site in 1 country.
About this study
This is a retrospective cohort study utilizing radiographic and computed tomography (CT) imaging data collected during routine clinical care at Schulthess Klinik Zürich. The study focuses on developing and validating artificial intelligence (AI)-based tools for the assessment of trapeziometacarpal (TMC) joint osteoarthritis (OA) and implant monitoring.
The project is divided into four subprojects: (1) development of a new radiographic classification system for TMC OA, (2) automation of the classification using deep learning, (3) automated detection of implant migration, and (4) 3-dimensional (3D) reconstruction of the TMC joint from biplanar radiographs.
Read more
Data will be sourced from two cohorts: patients from our clinical TMC arthroplasty registry who received the Touch implant, and patients with other wrist-related conditions who underwent radiographic imaging with a visible TMC joint. Together, these cohorts provide a broad coverage across the full spectrum of OA severity.
OA-related features and implant related features will serve as the foundation for model training and validation. Also, they will be validated with CT images regarding reliability and accuracy. The resulting prototypes for automated OA staging, implant migration detection, and 3D modeling of the TMC joint are exclusively used for research purposes. Any future clinical use of these tools, including evaluation under Swissmedic (Swiss Agency for Therapeutic Products) regulations, will be part of a separate project.
- Conditions
- Thumb Osteoarthritis
- Being tested
- No Intervention: Observational Cohort
- Keywords
- Thumb Saddle Joint, Osteoarthritis, Artificial Intelligence, Carpometacarpal, Trapeziometacarpal, CMC I, TMC, 3D Reconstruction, Implant migration, Computer Vision
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
No Intervention: Observational Cohort
| Study group | Role | What they receive |
|---|---|---|
| Osteoarthritis | Patients in our TMC arthroplasty registry (Business Administration System for Ethics Committees (BASEC) number: 2019-02096): Patients who received a Touch implant for TMC joint arthroplasty. Data will be included in the study from the creation of the registry in 2018 until the end of January 2028. Receives: Other: No Intervention: Observational Cohort | |
| Healthy | Patients with other clinical conditions leading to TMC joint radiography. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
New TMC OA classification
Create a novel classification system for TMC OA based on joint and bone features in X-rays. This system should ensure better reliability, accurately reflect joint health, and provide clinically relevant insights for treatment decisions.
Measured: Preoperative
Automation of the new TMC OA classification
Implement a deep learning-based system to automate TMC joint OA classification in plain radiographs using convolutional neural networks for segmentation and feature extraction. This approach aims to improve consistency and reduce the need for manual annotations.
Measured: Preoperative
Automated implant migration detection
Develop an AI-based system for detecting implant loosening and migration in postoperative radiographs, for early detection of loosening and long-term monitoring of implant stability.
Measured: Postoperative
3D reconstruction of the TMC joint
Create a 3D reconstruction of the trapezium and the first metacarpal from biplanar radiographs. This provides advanced insights into individual trapezium geometry to improve surgical planning.
Measured: Preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thumb OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148349
- Sponsor's protocol ID
- OE-0259
- Acronym
- TMCAI
- Status last verified
- Apr 2026
- First submitted
- 21 Aug 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared. The study involves sensitive clinical data that is subject to privacy protections and institutional regulations. Ownership of the data remains with the clinic, and confidentiality requirements prevent making these data publicly available.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence in Trapeziometacarpal Joint Osteoarthritis: Improving Assessment and Clinical Decision-Making
- ClinicalTrials.gov ID
- NCT07148349
- Acronym / sponsor ID
- TMCAI / OE-0259
- Conditions
- Thumb Osteoarthritis
- Keywords
- Thumb Saddle Joint, Osteoarthritis, Artificial Intelligence, Carpometacarpal, Trapeziometacarpal, CMC I, TMC, 3D Reconstruction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Collaborators
- ETH Zurich (Switzerland)
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Aug 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 is a retrospective cohort study utilizing radiographic and computed tomography (CT) imaging data collected during routine clinical care at Schulthess Klinik Zürich. The study focuses on developing and validating artificial intelligence (AI)-based tools for the assessment of trapeziometacarpal (TMC) joint osteoarthritis (OA) and implant monitoring.
The project is divided into four subprojects: (1) development of a new radiographic classification system for TMC OA, (2) automation of the classification using deep learning, (3) automated detection of implant migration, and (4) 3-dimensional (3D) reconstruction of the TMC joint from biplanar radiographs.
Data will be sourced from two cohorts: patients from our clinical TMC arthroplasty registry who received the Touch implant, and patients with other wrist-related conditions who underwent radiographic imaging with a visible TMC joint. Together, these cohorts provide a broad coverage across the full spectrum of OA severity.
OA-related features and implant related features will serve as the foundation for model training and validation. Also, they will be validated with CT images regarding reliability and accuracy. The resulting prototypes for automated OA staging, implant migration detection, and 3D modeling of the TMC joint are exclusively used for research purposes. Any future clinical use of these tools, including evaluation under Swissmedic (Swiss Agency for Therapeutic Products) regulations, will be part of a separate project.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteoarthritis | – | Other: No Intervention: Observational CohortPatients in our TMC arthroplasty registry (Business Administration System for Ethics Committees (BASEC) number: 2019-02096): Patients who received a Touch implant for TMC joint arthroplasty. Data will be included in the study from the creation of the registry in 2018 until the end of January 2028. |
| Healthy | – | Other: No Intervention: Observational CohortPatients with other clinical conditions leading to TMC joint radiography. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population consists of patients treated at Schulthess Klinik Zürich with available radiographic imaging of the TMC joint. Data are derived from two cohorts: (1) patients enrolled in the TMC arthroplasty registry (BASEC number: 2019-02096) who received a Touch implant since 2018, and (2) patients with other wrist-related conditions requiring radiographs in which the TMC joint is clearly visible. The combined cohorts provide a balanced representation across the spectrum of TMC joint OA severity, from healthy joints to end-stage disease.
Key inclusion criteria (5 listed)
- Patients will be included in the study if they have provided written general consent for the use of their clinical data and meet the requirements of one of the following two groups:
- Patients who received a Touch implant for TMC joint arthroplasty and are documented in our clinical registry
- Patients who underwent radiographic imaging for one of the following conditions, with a clearly visible TMC joint, for example: Distal radius fracture, carpal fracture, finger dislocation, or similar.
Key exclusion criteria (9 listed)
- Patients with posttraumatic OA.
- Patients with rheumatoid arthritis.
- Eaton Littler score higher than one.
- Prior surgery affecting the trapezium or the first metacarpal.
- Clinical condition resulting in abnormal TMC joint morphology.
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 |
|---|---|---|
| No Intervention: Observational CohortNo Intervention: Observational Cohort | Other | Healthy, Osteoarthritis |
Primary outcome
New TMC OA classification
Time frame: Preoperative
Create a novel classification system for TMC OA based on joint and bone features in X-rays. This system should ensure better reliability, accurately reflect joint health, and provide clinically relevant insights for treatment decisions.
Automation of the new TMC OA classification
Time frame: Preoperative
Implement a deep learning-based system to automate TMC joint OA classification in plain radiographs using convolutional neural networks for segmentation and feature extraction. This approach aims to improve consistency and reduce the need for manual annotations.
Automated implant migration detection
Time frame: Postoperative
Develop an AI-based system for detecting implant loosening and migration in postoperative radiographs, for early detection of loosening and long-term monitoring of implant stability.
3D reconstruction of the TMC joint
Time frame: Preoperative
Create a 3D reconstruction of the trapezium and the first metacarpal from biplanar radiographs. This provides advanced insights into individual trapezium geometry to improve surgical planning.
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 30 Apr 2026.
- Individual participant dataSharing planned: No. IPD will not be shared. The study involves sensitive clinical data that is subject to privacy protections and institutional regulations. Ownership of the data remains with the clinic, and confidentiality requirements prevent making these data publicly available.
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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.
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?
An observational study of Thumb Osteoarthritis, run by Schulthess Klinik at 1 site in Switzerland.
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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 30 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 Switzerland. 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?
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?
New TMC OA classification (time frame: Preoperative). The study lists 4 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 30 Apr 2026.