Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: This is a non interventional registry.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
Overview
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.
Detailed description
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.
Interventions
- Other This is a non interventional registry
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 outcome measures
- Proportion of patients that are using the braces [Time frame: 6 months follow up]
- Change in Pain status compared to baseline [Time frame: 6 months follow up]
- Change in Mobility compared to baseline [Time frame: 6 months follow up]
- Proportion of patients that are still using the braces [Time frame: 1 year follow up]
- Change in Pain status compared to baseline [Time frame: 1 year follow up]
- Change in Mobility compared to baseline [Time frame: 1 year follow up]
- Sick leave after receiving the braces [Time frame: 6 months follow up]
- Sick leave after receiving the braces [Time frame: 1 year follow up]
- Changes in reported quality of life [Time frame: 6 months follow up]
- Changes in reported quality of life [Time frame: 1 year follow up]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Sweden · 1 center
- Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm — Hässleholm
Identifiers
NCT: NCT04651673 · CIP2020050839