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NCT Number: NCT04364334

Knee Registry (Knieregister)

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.

Recruiting

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Key information

Conditions

Knee Pathology Arthritis Bone Diseases Chondral Defect Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Osteochondral Defect Osteochondritis Osteochondritis Dissecans Rheumatic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location status: Recruiting

Location contact

Roel Custers, Dr

CONTACT

[email protected]

0887558327 ext. +31

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Patient characteristics and medical data

    Time frame: Status at baseline.

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

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. Change in SF-36

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

    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.

  6. 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.

    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.

  7. 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.

    Question about the pain on a scale of 0 to 10 during rest and activity. 0 indicating no pain, 10 indicating extreme pain.

  8. Change in Tegner

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

    Question about the level of work and sports activity on a scale from 0 to 10, where 10 indicates a high level of activity.

  9. Anker questions

    Time frame: After treatment at 3, 6 and 12 months

    Questions about the results of surgery for functionality, pain and satifaction. Descriptive.

  10. 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.

    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.

  11. Change in healthcare use and costs

    Time frame: Before treatment, and after treatment at 6, 9 (only for ACI patients) and 12 months.

    iMTA-questionnaire descriptive (Medical Consumption and Productivity Cost Questionnaire)

  12. Change in KOOS-PS (Knee Injury and Osteoarthritis Outcome Score-short form)

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Linda Kornegoor, MSc

CONTACT

[email protected]

088 75 69349 ext. +31

Roel Custers, Dr

CONTACT

[email protected]

088 75 58327

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2100
Study completion
2100
First posted
Apr 28, 2020
Registry last updated
Dec 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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