Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Erasmus Medical Center | OTHER |
| University of Rotterdam, The Netherlands | OTHER |
Not provided
Not provided
Not provided
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:
The grid space will be kept moderate in size to balance comprehensiveness with computational feasibility, ensuring a thorough exploration of important hyperparameters while avoiding an overly exhaustive search.
In developing our model, the investigators will aim to enhance the performance and reduce overfitting by employing feature selection to address collinearity. The investigators will also investigate a minimal feature set using feature importance scores from an initial XGBoost model as well as expert knowledge to prioritize clinically relevant predictors. Lastly, the investigators will explore feature engineering (e.g., polynomial transformations) to enhance the predictive power of our model.
Model evaluation:
Held-Out Test Set: After internal validation and hyperparameter tuning, the final model will be evaluated on the 30% held-out test set to assess its performance on unseen data, providing an unbiased estimate of generalizability.
Performance Metrics:
Learning Curve: Learning curves will be employed to evaluate the model performance across different training set sizes. By plotting training and validation errors against the number of training sample sizes (subsets of whole dataset), the investigators can assess the model fit, observe the learning behavior, and determine whether our model performance would benefit from additional training data.
Prediction Uncertainty: The investigators will use bootstrap aggregation (bagging), following methods from Hastie et al., to obtain prediction intervals, which quantify uncertainty in individual XGBoost predictions by analyzing the variance in prediction errors across bootstrap samples. Unlike confidence intervals, these intervals account for both model misspecification and outcome uncertainty.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Touch® patients | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Touch® Trapeziometacarpal Joint Arthroplasty | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 1 year after surgery |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schulthess Klinik | Zurich | Canton of Zurich | 8008 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35415551 | Background | Hamasaki T, Harris PG, Bureau NJ, Gaudreault N, Ziegler D, Choiniere M. Efficacy of Surgical Interventions for Trapeziometacarpal (Thumb Base) Osteoarthritis: A Systematic Review. J Hand Surg Glob Online. 2021 Mar 23;3(3):139-148. doi: 10.1016/j.jhsg.2021.02.003. eCollection 2021 May. | |
| 21193136 | Background |
Not provided
Not provided
We do not plan on sharing the raw data. The full analysis code will be shared.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D014110 | Touch |
| ID | Term |
|---|---|
| D012677 | Sensation |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vermeulen GM, Slijper H, Feitz R, Hovius SE, Moojen TM, Selles RW. Surgical management of primary thumb carpometacarpal osteoarthritis: a systematic review. J Hand Surg Am. 2011 Jan;36(1):157-69. doi: 10.1016/j.jhsa.2010.10.028. |
| 36855785 | Background | Falkner F, Tumkaya AM, Thomas B, Panzram B, Bickert B, Harhaus L. Dual mobility prosthesis for trapeziometacarpal osteoarthritis: results from a prospective study of 55 prostheses. J Hand Surg Eur Vol. 2023 Jun;48(6):566-574. doi: 10.1177/17531934231156280. Epub 2023 Feb 28. |
| 37310049 | Background | Herren DB, Marks M, Neumeister S, Schindele S. Low complication rate and high implant survival at 2 years after Touch(R) trapeziometacarpal joint arthroplasty. J Hand Surg Eur Vol. 2023 Oct;48(9):877-883. doi: 10.1177/17531934231179581. Epub 2023 Jun 13. |
| 25559974 | Background | Bertozzi L, Valdes K, Vanti C, Negrini S, Pillastrini P, Villafane JH. Investigation of the effect of conservative interventions in thumb carpometacarpal osteoarthritis: systematic review and meta-analysis. Disabil Rehabil. 2015;37(22):2025-43. doi: 10.3109/09638288.2014.996299. Epub 2015 Jan 5. |
| 37903291 | Background | Esteban Lopez LMJ, Hoogendam L, Vermeulen GM, Tsehaie J, Slijper HP, Selles RW, Wouters RM; The Hand-Wrist Study Group. Long-Term Outcomes of Nonsurgical Treatment of Thumb Carpometacarpal Osteoarthritis: A Cohort Study. J Bone Joint Surg Am. 2023 Dec 6;105(23):1837-1845. doi: 10.2106/JBJS.22.01116. Epub 2023 Oct 30. |
| 20124359 | Background | Bijsterbosch J, Visser W, Kroon HM, Stamm T, Meulenbelt I, Huizinga TW, Kloppenburg M. Thumb base involvement in symptomatic hand osteoarthritis is associated with more pain and functional disability. Ann Rheum Dis. 2010 Mar;69(3):585-7. doi: 10.1136/ard.2009.104562. Epub 2010 Feb 2. |
| 20807622 | Background | Gehrmann SV, Tang J, Li ZM, Goitz RJ, Windolf J, Kaufmann RA. Motion deficit of the thumb in CMC joint arthritis. J Hand Surg Am. 2010 Sep;35(9):1449-53. doi: 10.1016/j.jhsa.2010.05.026. |
| 25626796 | Background | Bakri K, Moran SL. Thumb carpometacarpal arthritis. Plast Reconstr Surg. 2015 Feb;135(2):508-520. doi: 10.1097/PRS.0000000000000916. |
| 33744429 | Background | van der Oest MJW, Duraku LS, Andrinopoulou ER, Wouters RM, Bierma-Zeinstra SMA, Selles RW, Zuidam JM. The prevalence of radiographic thumb base osteoarthritis: a meta-analysis. Osteoarthritis Cartilage. 2021 Jun;29(6):785-792. doi: 10.1016/j.joca.2021.03.004. Epub 2021 Mar 17. |
| 21622766 | Background | Haugen IK, Englund M, Aliabadi P, Niu J, Clancy M, Kvien TK, Felson DT. Prevalence, incidence and progression of hand osteoarthritis in the general population: the Framingham Osteoarthritis Study. Ann Rheum Dis. 2011 Sep;70(9):1581-6. doi: 10.1136/ard.2011.150078. Epub 2011 May 27. |
| 30509411 | Background | Kloppenburg M, van Beest S, Kroon FPB. Thumb base osteoarthritis: A hand osteoarthritis subset requiring a distinct approach. Best Pract Res Clin Rheumatol. 2017 Oct;31(5):649-660. doi: 10.1016/j.berh.2018.08.007. Epub 2018 Sep 26. |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |