An observational study in Osteoarthritis, Thumb Arthritis and Arthroplasty of the MCP Joint, sponsored by Michael Oyewale. Active, not recruiting at 1 site in Switzerland. Per ClinicalTrials.gov, last updated 2024-12-20.
Sponsored by Michael Oyewale · Observational
This study aims to develop a predictive model to help doctors better understand expected outcomes one year after thumb joint surgery for osteoarthritis. By analyzing clinical and patient-reported data from individuals who underwent surgery with the Touch® implant, the study seeks to predict pain levels and hand function 1-year after surgery. This information can support shared decision-making, set realistic expectations, and improve personalized treatment planning.
This study aims to develop and validate predictive models for assessing pain and hand function outcomes one year after trapeziometacarpal joint (TMJ) arthroplasty using the Touch® prosthesis. The study leverages a single-center prospective registry from a specialized orthopedic hospital in Zurich, Switzerland.
Analytical methods:
The investigators will use the following modeling approach to determine the best predictive value for the 1-year outcome of pain. The model chosen is:
- Extreme Gradient Boosting (XGBoost): A non-parametric, ensemble-based approach that combines decision trees through boosting to capture complex feature interactions and model non-linearity effectively. XGBoost also includes L1 and L2 regularization, allowing it to manage overfitting while providing strong predictive performance. XGBoost is known for its superior performance in capturing intricate relationships, providing robust predictions across various data contexts, as well as obtaining the first prize in many AI datathons.
Missing data:
The investigators anticipate missing data for patient-reported, clinical, radiological and supplementary variables. To address this, the investigators will
Model development:
Extreme Gradient Boosting (XGBoost):
The data will be split into a training (70%) and testing (30%) set. The XGBoost model will be trained using hyperparameter tuning through grid search combined with repeated 5-fold cross-validation (repeated 5 times) on the training set. This repeated cross-validation serves as internal validation to ensure robust and unbiased estimation of model performance during training. The grid space search will explore a reasonable range of values for key hyperparameters, such as:
Model evaluation:
Performance Metrics:
Model output:
The investigators will use the final model to develop a web-based outcome calculator for pain and function 1-year after surgery. This tool is intended primarily for use by the clinicians, aiming to facilitate shared decision-making with the patients. By providing clear visualizations and easy-to-understand classifications, the calculator will help clinicians explain potential outcomes to patients and support patient engagement in their treatment planning. The model output will include either the predicted pain score on a 0-10 Numeric Rating Scale (NRS) or the bMHQ hand function score, which ranges from 0-100.
Based on the outcome, the exact predicted values will be visually highlighted followingly:
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 330 is above the median of 100 across 803 observational studies indexed under Osteoarthritis.
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Study participants will be selected from a single-center prospective registry of patients treated at a specialized orthopedic hospital in Zurich, Switzerland. The population consists of individuals diagnosed with primary trapeziometacarpal joint (TMJ) osteoarthritis who underwent primary TMJ arthroplasty using the Touch® prosthesis. This population represents a mix of patients with varying severities of TMJ osteoarthritis who had failed conservative treatments such as splints, hand therapy, or corticosteroid injections before undergoing surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients who were treated with a primary trapeziometacarpal joint (TMJ) arthroplasty using the Touch® prosthesis for TMJ OA in our single-center prospective registry. Patients had usually received treatments with splints, hand therapy and 1-3 steroid injections before undergoing surgery. Specific indications for primary TMJ implant arthroplasty included good trapezial bone stock without cysts, a trapezial height of at least 8 mm, no clinically relevant scaphotrapezoidal OA and no severe instability of the metacarpophalangeal joint.
Procedure: Touch® Trapeziometacarpal Joint Arthroplasty
The intervention involves primary trapeziometacarpal joint (TMJ) arthroplasty using the Touch® prosthesis, a dual-mobility implant designed for the treatment of osteoarthritis in the thumb.
Also known as: Primary Trapeziometacarpal Joint Replacement, Thumb Joint Replacement with Touch® Implant
Pain During Activities at 1-Year Post-Surgery
Pain during activities will be measured using a Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (maximum pain). Participants rate the level of pain experienced during typical daily activities.
Time frame: 1 year after surgery
Hand Function at 1-Year Post-Surgery
Hand function will be assessed using the brief Michigan Hand Outcomes Questionnaire (bMHQ), which evaluates hand performance in various activities. Scores range from 0 to 100, with higher scores indicating better function.
Time frame: 1 year after surgery
Plan to share: No — We do not plan on sharing the raw data. The full analysis code will be shared.
This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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