Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 1,000,000
- 试验地点
- 1
- 主要终点
- Change in VAS pain (Visual Analogue Scale)
研究概览
简要总结
Rationale: In view of patient care, patient characteristics and treatment parameters are registered for all patients visiting the Mobility Clinic of the University Medical Center Utrecht for orthopaedic knee treatment. Patients also fill out questionnaires for function, pain and mobility of the knee, before and after treatment.
Objective: The main objective of this registry is to collect patient characteristics and treatment parameters together with data from the questionnaires in a database. This knee registry can be used for future research questions.
Study design: This is a longitudinal observational registry.
Study population: All patients that visit the Mobility Clinic will be asked to participate in the knee registry. Patients that meet one or more of the following criteria will be excluded: are below the age of 16, not able or willing to sign the broad consent form, not being able to read and understand Dutch language, or receiving medical treatment for their knee elsewhere.
Main study parameters/endpoints: Data will be collected for future research for which the purpose is not known at this time. When new research will be conducted, study parameters will be set. A study application has to be submitted to the institutional ethical review board of the University Medical Center Utrecht. Patients do not need to be asked permission for the use of their data for each study individually. Only when additional information is needed.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The burden for patients to participate in this registry is minimal and consists of time. Any future results may be beneficial for patients. Participation or refusal to participate in the registry has no consequences for their treatment.
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
- •Receives orthopaedic knee surgery or conservative knee treatment (advice, physiotherapy, injections etc) at the UMC Utrecht;
- •Able to read and understand Dutch language;
- •Is able and willing to signs the broad consent form.
排除标准
- •Receives no treatment (refusal of surgery or treatment);
- •Receives treatment elsewhere.
结局指标
主要结局
Change in VAS pain (Visual Analogue Scale)
时间窗: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Question about pain on on a horizontal visual analogue scale, where the endpoints are labelled 'no pain' and 'unbearable pain'. This is converted into a scale of 0-100 where a higher score indicates a higher level of pain.
Anker questions
时间窗: After treatment at 3, 6 and 12 months
Questions about the results of surgery for functionality, pain and satifaction. Descriptive.
Change in NRS pain (Numeric Rating Scale)
时间窗: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Question about the pain on a scale of 0 to 10 during rest and activity. 0 indicating no pain, 10 indicating extreme pain.
Change in OKS (Oxford knee score)
时间窗: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Questionnaire about the pain and limitations of activities for patients with a knee prosthesis. Maximal total score is 60, indicating the maximum level of pain or functional limitations.
Change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-short form)
时间窗: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Short form of the questionnaire for evaluating limitations and symptoms for patients with knee complaints. Scale of 0-100, where 100 indicates no symptoms and limitations and 0 an extreme amount of symptoms and limitations.
Patient characteristics and medical data
时间窗: Status at baseline.
General patient characteristics, medical data, and specific knee data.
Change in EQ5D (EuroQol 5 dimensions)
时间窗: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
The EQ-5D-5L is a questionnaire about the quality of life on a scale of 0-100 and has 5 dimensions, each dimension has 5 levels. A higher score indicates a higher health utility. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
时间窗: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Questionnaire for evaluating limitations and symptoms for patients with knee complaints. Scale of 0-100, where 100 indicates no symptoms and limitations and 0 an extreme amount of symptoms and limitations.
Change in IKDC (International Knee Documentation Committee)
时间窗: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Questionnaire about symptoms and function for patients with knee complaints. Scale of 0-100 where 100 indicates the highest level of function and lowest level of symptoms.
Change in SF-36
时间窗: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Questionnaire about the health related quality of life. There are several subcategories on a scale of 0-100, where a higher score indicates a better health related quality of life.
Change in Tegner
时间窗: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Question about the level of work and sports activity on a scale from 0 to 10, where 10 indicates a high level of activity.
Change in healthcare use and costs
时间窗: Before treatment, and after treatment at 6, 9 (only for ACI patients) and 12 months.
iMTA-questionnaire descriptive (Medical Consumption and Productivity Cost Questionnaire)
次要结局
未报告次要终点
研究者
R.J.H. Custers
Principal Investigator
UMC Utrecht