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| Name | Class |
|---|---|
| Region Skane | OTHER |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients that are using the braces | brace usage, days per week | 6 months follow up |
| Change in Pain status compared to baseline | Knee injury and Osteoarthritis Outcome Score (KOOS)-12 | 6 months follow up |
| Change in Mobility compared to baseline | KOOS-12 | 6 months follow up |
| Proportion of patients that are still using the braces | brace usage, days per week | 1 year follow up |
| Change in Pain status compared to baseline | KOOS-12 | 1 year follow up |
| Change in Mobility compared to baseline | KOOS-12 | 1 year follow up |
| Sick leave after receiving the braces | Proportion of sick leave | 6 months follow up |
| Sick leave after receiving the braces | Proportion of sick leave | 1 year follow up |
| Changes in reported quality of life |
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| Measure | Description | Time Frame |
|---|---|---|
| The patients' satisfaction of the value/effectiveness of the brace | Numeric Rating Scale (NRS) for satisfaction (0-10) | 6 months follow up |
| The patients' satisfaction of the value/effectiveness of the brace |
Inclusion Criteria:
Exclusion Criteria:
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Subjects are patients that have been prescribed knee braces for treatment of knee OA. The brace prescription is independent of the registry, i.e. no one is prescribed a brace because of the registry or for the purpose of this data collection per se
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Dencker, Dr | Region Skane | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm | Hässleholm | Skåne County | Sweden |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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KOOS-12 |
| 6 months follow up |
| Changes in reported quality of life | KOOS-12 | 1 year follow up |
| Changes in QALY's | EQ-5D-5L | 6 months follow up |
| Changes in QALY's | EQ-5D-5L | 1 year follow up |
NRS for satisfaction (0-10)
| 1 year follow up |
| D012216 |
| Rheumatic Diseases |