Knee Registry (Knieregister)
Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.
1 other identifier
observational
1,000,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 15, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2100
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2100
December 5, 2023
November 1, 2023
83.1 years
April 15, 2020
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Patient characteristics and medical data
General patient characteristics, medical data, and specific knee data.
Status at baseline.
Change in EQ5D (EuroQol 5 dimensions)
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.
Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
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.
Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Change in IKDC (International Knee Documentation Committee)
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.
Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in SF-36
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.
Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in VAS pain (Visual Analogue Scale)
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.
Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in NRS pain (Numeric Rating Scale)
Question about the pain on a scale of 0 to 10 during rest and activity. 0 indicating no pain, 10 indicating extreme pain.
Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
Change in Tegner
Question about the level of work and sports activity on a scale from 0 to 10, where 10 indicates a high level of activity.
Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Anker questions
Questions about the results of surgery for functionality, pain and satifaction. Descriptive.
After treatment at 3, 6 and 12 months
Change in OKS (Oxford knee score)
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.
Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Change in healthcare use and costs
iMTA-questionnaire descriptive (Medical Consumption and Productivity Cost Questionnaire)
Before treatment, and after treatment at 6, 9 (only for ACI patients) and 12 months.
Change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-short form)
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.
Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Study Arms (1)
Knee registry patients
Eligibility Criteria
Patients that visit the Mobility Clinic at the UMC Utrecht for their knee pathology.
You may qualify if:
- 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.
You may not qualify if:
- Receives no treatment (refusal of surgery or treatment);
- Receives treatment elsewhere.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UMC Utrechtlead
Study Sites (1)
University Medical Center Utrecht
Utrecht, 3584 CX, Netherlands
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roel Custers, Dr
Orthopedic surgeon
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 15, 2020
First Posted
April 28, 2020
Study Start
January 1, 2017
Primary Completion (Estimated)
January 1, 2100
Study Completion (Estimated)
January 1, 2100
Last Updated
December 5, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- In view of the regulation for clinical trials, the investigators need to save all data for at least 15 years with the goal to be able to go back to patient level. After finishing the project all documents and data are stored at the UMC Utrecht.
- Access Criteria
- The data manager keeps the linking table to personal data.
New research questions that requires data from the registry need to be discussed and approved by the PI and data manager/coordinator of this registry. The proposal should also be in agreement with the research collaboration and data transfer guidelines and agreements of the UMC Utrecht. Proposals need to be submitted to the institutional ethical review board of the University Medical Center Utrecht. After review, the data selection will be provided to the researcher.