Pilot Study: Development of an Outcome Score for Patients With Knee Osteoarthritis and/or Knee Joint Endoprosthesis Using an App Developed at the Clinic for Orthopedics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,250
- 试验地点
- 2
- 主要终点
- overall patient satisfaction
研究概览
简要总结
Total knee arthroplasty (TKA) and total hip arthroplasty (THA) is one of the most frequent orthopedic procedures. Over 50% of patients report higher expectations than their surgeons, and 10-50% remain dissatisfied postoperatively. Persistent pain, functional limitations, and unmet expectations are key drivers. Identifying risks pre- and early postoperatively is essential, alongside empowering patients through self-management.
Existing scoring systems integrate PROMs, demographics, and sometimes imaging but within limited timeframes. They rarely capture functional deficits or long-term trajectories. Digital health solutions for TKA (pre-)rehabilitation exist, yet most focus on physiotherapy and education rather than predictive outcome modeling.
To address this gap, the study team has developed a novel mobile application that enables the documentation and analysis of movement data up to 10 years before surgery and throughout long-term follow-up. These data are combined with PROMs and functional test results, providing a unique basis for outcome prediction and risk stratification in TKA/THA.
Primary Objective The aim of this pilot study is to develop a composite outcome score for TKA/THA patients. This score will integrate demographic variables, PROMs, and objective functional measures (knee joint angles, gait parameters, walk tests) to identify risk factors for dissatisfaction and support predictive modeling. A machine learning algorithm will be trained using the collected dataset to predict patient satisfaction after TKA/THA.
Endpoints Primary endpoint: Overall patient satisfaction Secondary endpoints: Age, height, weight, step count, step length, gait asymmetry, gait speed, double support phase, knee joint ROM, walk test, KOOS, SF-36, EQ5d, satisfaction with the app, and satisfaction with app use.
Study Population App-Group: Inclusion criteria are patients ≥18 years before or after TKA/THA. Exclusion criteria include missing consent, ineligible diagnosis, lack of smartphone, age <18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.
Non-App-Group: Inclusion criteria are patients ≥18 years before or after TKA/THA. Exclusion criteria include missing consent, ineligible diagnosis, age <18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.
Healthy-group: Inclusion criteria are healthy proband ≥18 years with no lower limb conditions. The overall procedure is identical to that of the AppGroup. Exclusion criteria include missing consent, ineligible diagnosis, no smartphone, age <18 years, or insufficient German language skills (as no English version of the app is currently available). Planned enrollment: 450 patients.
Methods Design: Single-center, prospective pilot study. The app collects patient-authorized movement data already stored on smartphones as well as future data. Participants choose which data to share. In addition, they are prompted to complete gait tests and knee function tests. PROMs (KOOS, SF-36, satisfaction) are administered at regular intervals.
详细描述
Background:
In routine medical practice, only limited objective long-term data on patients' physical activity and its progression during the course of disease are typically available. Similarly, longitudinal information from patient-reported outcome measures (PROMs) or functional tests is often lacking. In musculoskeletal disorders in particular, combining subjective complaints with data on patients' everyday movement behavior is crucial for guiding further diagnostic or therapeutic decisions and for risk assessment.
Following total knee arthroplasty (TKA), more than 50% of patients report higher expectations for their surgical outcome than their treating surgeons. Between 10% and 50% of patients remain dissatisfied with the overall outcome after TKA/THA. Persistent pain is among the main reasons for such dissatisfaction. Functional musculoskeletal limitations and unmet expectations regarding the outcome further contribute to long-term dissatisfaction. Additional risk factors for an unsatisfactory outcome include younger age, female sex, higher BMI, limited radiographic severity of osteoarthritis preoperatively (likely reflecting minor functional deficits), and psychological factors such as catastrophizing, depression, and anxiety.
To sustainably improve patient satisfaction, these risk factors must be identified and analyzed both preoperatively and in the early postoperative period, and the results must be communicated clearly to patients and healthcare providers. Patient self-management plays an essential role in this context. Patients should be empowered to actively improve their postoperative outcomes by addressing modifiable risk factors through targeted self-directed strategies.
Existing scoring systems generally focus on integrating clinical parameters such as PROMs, demographic data, and, in some cases, imaging within limited timeframes. However, they usually do not incorporate musculoskeletal functional deficits or long-term continuous pre- and postoperative trajectories.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 18 years or older
- •german speaking
- •signed informed consent
- •using own smartphone
排除标准
- •age below 18 years.
- •Lack of informed consent
- •no smartphone
- •non-German-speaking
研究组 & 干预措施
App-Group
Group which is using the app before and after TKA
干预措施: KneeApp (Other)
Non-App Group
In this arm, patients with osteoarthritis or those who have undergone TKA/THA surgery are included without using the app. These patients receive the same questionnaires as the app group by post, with a request to complete and return them. The patients do not need to play any further active role in the study.
Healthy controls
In this arm, healthy participants with no lower limb conditions are given the app. This group receives the same questionnaires as all other groups and completes the gait tests in the same way as the app group comprising patients with the condition. The overall procedure is identical to that of the app group comprising patients with the condition.
干预措施: KneeApp (Other)
结局指标
主要结局
overall patient satisfaction
时间窗: through study completion, an average of 1 year
satisfaction scale minimum: 0 = not satisfied, maximum: 5 = fully satisfied
次要结局
- age(through study completion, an average of 1 year)
- sex(through study completion, an average of 1 year)
- height(through study completion, an average of 1 year)
- Weight(through study completion, an average of 1 year)
- KOOS(through study completion, an average of 1 year)
- SF-36(through study completion, an average of 1 year)
- Knee range of motion(through study completion, an average of 1 year)
- 2-Minute walking test(through study completion, an average of 1 year)
- App feedback(through study completion, an average of 1 year)
- step count(through study completion, an average of 1 year)
- stride length(through study completion, an average of 1 year)
- gait speed(through study completion, an average of 1 year)
- double stance phase(through study completion, an average of 1 year)
研究者
Christina Valle
Dr. med.
Technical University of Munich