Knee Registry (Knieregister)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Knee Pathology, Osteoarthritis, Knee, Osteochondritis Dissecans, Chondral Defect. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.
Overview
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.
Primary outcome measures
- Patient characteristics and medical data [Time frame: Status at baseline.]
- Change in EQ5D (EuroQol 5 dimensions) [Time frame: 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) [Time frame: 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) [Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
- Change in SF-36 [Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
- Change in VAS pain (Visual Analogue Scale) [Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
- Change in NRS pain (Numeric Rating Scale) [Time frame: 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 [Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
- Anker questions [Time frame: After treatment at 3, 6 and 12 months]
- Change in OKS (Oxford knee score) [Time frame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Receives no treatment (refusal of surgery or treatment);
- Receives treatment elsewhere.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- University Medical Center Utrecht — Utrecht
Identifiers
NCT: NCT04364334 · 17-005