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Enrolling by Invitation

NCT Number: NCT04651673

Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)

The study is a non-controlled retro- and prospective multi center patient registry study.

Subjects will be given a study ID number assigned at first brace fitting after consenting to partake. Participants will be asked to fill in a questionnaire either in electronic or paper version at first fitting. Additional follow up questionnaires will be implemented at 4 weeks, 6 months and 1 year post initial brace fitting. After that period patients will be contacted every year, until brace termination/ knee surgery or death.

Enrolling by Invitation

Interested in participating?

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm

Hässleholm, Skåne County, Sweden

About this study

This is a noninterventional registry study pertaining to knee OA braces. There are no comparative devices or treatments. Subjects are expected to follow the recommendations of the brace subscriber and other health care professionals at any time independent of their continuation within the registry.

Subjects will be enrolled at the clinic where their brace was prescribed or at the site where the brace was fitted.

There is no formal end date for this data registry. A revisit to this protocol may be motivated after 5 years, to assess if longer follow up is required.

For individual participants follow up will continue with annual questionnaires as long as the brace is in use. The questionnaires will be administered either through mail with a paper version, or through a link to an electronical version (ePRO). There is also a possibility of administrating the questionnaires as a phone guided interview, if that is a mean that serves the patient or clinics better. The planned follow-ups are at 4 weeks, 6 months, 1 year from brace prescription and then annually as long as participants are disposed as "ongoing" in the registry.

The questionnaires contains question about pain, function, medication, general brace use and quality of life question.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients that are prescribed knee brace for symptomatic treatment of knee OA from partaking clinics
  • Older than 18 years

Exclusion criteria

  • Younger than 18 years
  • Not willing or able to sign informed consent, or not cognitive impairments preventing understanding of the questionnaires.

Treatment and study plan

This is a non interventional registry

Other

All patients, at listed investigational sites, that get prescription for a knee orthosis indicated for Knee OA symptomatic treatment, get an invite to partake in the evaluation registry.

Primary outcomes

  1. Proportion of patients that are using the braces

    Time frame: 6 months follow up

    brace usage, days per week

  2. Change in Pain status compared to baseline

    Time frame: 6 months follow up

    Knee injury and Osteoarthritis Outcome Score (KOOS)-12

  3. Change in Mobility compared to baseline

    Time frame: 6 months follow up

    KOOS-12

  4. Proportion of patients that are still using the braces

    Time frame: 1 year follow up

    brace usage, days per week

  5. Change in Pain status compared to baseline

    Time frame: 1 year follow up

    KOOS-12

  6. Change in Mobility compared to baseline

    Time frame: 1 year follow up

    KOOS-12

  7. Sick leave after receiving the braces

    Time frame: 6 months follow up

    Proportion of sick leave

  8. Sick leave after receiving the braces

    Time frame: 1 year follow up

    Proportion of sick leave

  9. Changes in reported quality of life

    Time frame: 6 months follow up

    KOOS-12

  10. Changes in reported quality of life

    Time frame: 1 year follow up

    KOOS-12

  11. Changes in QALY's

    Time frame: 6 months follow up

    EQ-5D-5L

  12. Changes in QALY's

    Time frame: 1 year follow up

    EQ-5D-5L

Other outcomes

  1. The patients' satisfaction of the value/effectiveness of the brace

    Time frame: 6 months follow up

    Numeric Rating Scale (NRS) for satisfaction (0-10)

  2. The patients' satisfaction of the value/effectiveness of the brace

    Time frame: 1 year follow up

    NRS for satisfaction (0-10)

Sponsors and collaborators

Lead sponsor

Össur Iceland ehf

Industry

Collaborators

  • Region Skane

Registry information

Official study title

Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Dec 3, 2020
Registry last updated
Aug 11, 2025

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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