Knee Registry (Knieregister)

Osteoarthritis, Knee Clinical Trial

Official title:

Collecting Diagnostic, Treatment and Follow-up Data on Knee Treatments.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04364334
• Other study ID #: 17-005
• Status: Recruiting
• Start date: January 2017
• Est. completion date: January 2100

Study information

• Verified date: November 2023
• Source: UMC Utrecht
• Contact: Linda Kornegoor, MSc
• Phone: 088 75 69349
• Email: l.kornegoor[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: January 2100
• Est. primary completion date: January 2100
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chondral Defect
• Knee Pathology
• Osteoarthritis, Knee
• Osteochondral Defect
• Osteochondritis
• Osteochondritis Dissecans

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient characteristics and medical data	General patient characteristics, medical data, and specific knee data.	Status at baseline.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Anker questions	Questions about the results of surgery for functionality, pain and satifaction. Descriptive.	After treatment at 3, 6 and 12 months
Primary	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.
Primary	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.
Primary	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.

External Links

•   Het knieregister: register voor kniebehandelingen
•   ICRS Patient Registry
•   Knee joint distraction in regular care for treatment of knee osteoarthritis: A comparison with clinical trial data.
•   Reduction of pin tract infections during external fixation using cadexomer iodine