Knee Registry (Knieregister)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis, Knee; Chondral Defect; Osteochondritis Dissecans; Osteochondral Defect; Knee Pathology

• Study Type: Observational
• Enrollment (Estimated): 1000000

Contacts and Locations

• Study Contact: Name: Roel Custers, Dr; Phone Number: 088 75 58327; Email: r.j.h.custers@umcutrecht.nl
• Study Contact Backup: Name: Linda Kornegoor, MSc; Phone Number: +31 088 75 69349; Email: l.kornegoor@umcutrecht.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • Recruiting
    • University Medical Center Utrecht
    • Contact: Roel Custers, Dr; Phone Number: +31 0887558327; Email: r.j.h.custers@umcutrecht.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Knee registry patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Roel Custers, Dr, Orthopedic Surgeon

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): January 1, 2100
• Study Completion (Estimated): January 1, 2100

Study Registration Dates

• First Submitted: April 15, 2020
• First Submitted That Met QC Criteria: April 24, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Bone Diseases; Osteoarthritis; Cartilage Diseases; Osteoarthritis, Knee; Osteochondritis; Osteochondritis Dissecans
• Other Study ID Numbers: 17-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: The data manager keeps the linking table to personal data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No