Schulthess Klinik
Zurich, Canton of Zurich, 8008, Switzerland
NCT Number: NCT06740851
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 is active but is not currently recruiting participants.
All sexes
Observational
Zurich, Canton of Zurich, 8008, Switzerland
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:
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):
Model evaluation:
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Primary Trapeziometacarpal Joint Replacement, Thumb Joint Replacement with Touch® Implant
Time frame: 1 year after 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 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.
Michael Oyewale
Other
A Study Protocol for the Development of a Predictive Model for 1-Year Pain and Function Outcomes After Touch® Trapeziometacarpal Joint Arthroplasty
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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