Knee Registry (Knieregister)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUMC Utrecht

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Receives no treatment (refusal of surgery or treatment);

Receives treatment elsewhere.

Trial population

Patients that visit the Mobility Clinic at the UMC Utrecht for their knee pathology.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000,000 Participants
are grouped into 1 trial group
Group A: Knee registry patients

Trial outcomes

Primary outcomes

1

Patient characteristics and medical data

General patient characteristics, medical data, and specific knee data.

Time frame
Status at baseline.
2

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.

Time frame
Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
3

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.

Time frame
Before treatment, and after treatment at 3, 6, 9 (only for ACI patients) and 12 months. Then annually up to 20 years.
4

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.

Time frame
Before treatment, and after treatment at 3, 6 and 12 months. Then annually up to 20 years.

Secondary outcomes

Other outcomes

Sponsors and contacts

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