A Study Protocol for the Development of a Predictive Model for 1-Year Pain and Function Outcomes After Touch® Trapeziometacarpal Joint Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Hand Function at 1-Year Post-Surgery
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were treated with a primary TMJ arthroplasty using the Touch® prosthesis for TMJ OA in our single-center prospective registry.
- •Patients who had completed their 1-year follow-up questionnaire
排除标准
- •Revision surgery,
- •Not treated for primary osteoarthritis (i.e., secondary osteoarthritis or rheumatoid arthritis or other),
- •Did not sign the consent form
结局指标
主要结局
Hand Function at 1-Year Post-Surgery
时间窗: 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.
Pain During Activities at 1-Year Post-Surgery
时间窗: 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.
次要结局
未报告次要终点
研究者
Michael Oyewale
Principal Investigator
Schulthess Klinik