Artificial Intelligence in Trapeziometacarpal Joint Osteoarthritis: Improving Assessment and Clinical Decision-Making (TMCAI)

Schulthess Klinik

Status: Not yet enrolling

Conditions: Thumb Osteoarthritis

Treatments: Other: No Intervention: Observational Cohort

Study type: Observational

Funder types: Other

Identifiers

NCT07148349

OE-0259

Details and patient eligibility

About

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.

Enrollment: 2,500 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
• 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 design

2,500 participants in 2 patient groups

Osteoarthritis

Description:

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.

Treatment:

Other: No Intervention: Observational Cohort

Healthy

Description:

Patients with other clinical conditions leading to TMC joint radiography.

Treatment:

Other: No Intervention: Observational Cohort