Clinical trial NCT04364334: Knee Registry (Knieregister)
Official title: Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Pathology
Osteoarthritis, Knee
Osteochondritis Dissecans
Chondral Defect
Osteochondral Defect
Keywords: Knee
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 1000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that visit the Mobility Clinic at the UMC Utrecht for their knee pathology.

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.


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.

Primary outcomes:
measure: Patient characteristics and medical data
timeFrame: Status at baseline.
measure: Change in EQ5D (EuroQol 5 dimensions)
timeFrame: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
measure: Change in KOOS (Knee Injury and Osteoarthritis Outcome Score)
timeFrame: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
measure: Change in IKDC (International Knee Documentation Committee)
timeFrame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
measure: Change in SF-36
timeFrame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
measure: Change in VAS pain (Visual Analogue Scale)
timeFrame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
measure: Change in NRS pain (Numeric Rating Scale)
timeFrame: Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
measure: Change in Tegner
timeFrame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
measure: Anker questions
timeFrame: After treatment at 3, 6 and 12 months
measure: Change in OKS (Oxford knee score)
timeFrame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
measure: Change in healthcare use and costs
timeFrame: Before treatment, and after treatment at 6, 9 (only for ACI patients) and 12 months.
measure: Change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-short form)
timeFrame: Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Orthopedic surgeon
name: Roel Custers, Dr
role: PRINCIPAL_INVESTIGATOR
References: