Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Proportion of patients that are using the braces [6 months follow up]
brace usage, days per week
- Change in Pain status compared to baseline [6 months follow up]
Knee injury and Osteoarthritis Outcome Score (KOOS)-12
- Change in Mobility compared to baseline [6 months follow up]
KOOS-12
- Proportion of patients that are still using the braces [1 year follow up]
brace usage, days per week
- Change in Pain status compared to baseline [1 year follow up]
KOOS-12
- Change in Mobility compared to baseline [1 year follow up]
KOOS-12
- Sick leave after receiving the braces [6 months follow up]
Proportion of sick leave
- Sick leave after receiving the braces [1 year follow up]
Proportion of sick leave
- Changes in reported quality of life [6 months follow up]
KOOS-12
- Changes in reported quality of life [1 year follow up]
KOOS-12
- Changes in QALY's [6 months follow up]
EQ-5D-5L
- Changes in QALY's [1 year follow up]
EQ-5D-5L
Other Outcome Measures
- The patients' satisfaction of the value/effectiveness of the brace [6 months follow up]
Numeric Rating Scale (NRS) for satisfaction (0-10)
- The patients' satisfaction of the value/effectiveness of the brace [1 year follow up]
NRS for satisfaction (0-10)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients that are prescribed knee brace for symptomatic treatment of knee OA from partaking clinics
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Older than 18 years
Exclusion Criteria:
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Younger than 18 years
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Not willing or able to sign informed consent, or not cognitive impairments preventing understanding of the questionnaires.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm | Hässleholm | Skåne | Sweden |
Sponsors and Collaborators
- Össur Ehf
- Region Skane
Investigators
- Principal Investigator: Sören Toksvig-Larsen, Dr, Region Skåne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CIP2020050839