Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 1,500
- Locations
- 1
- Primary Endpoint
- Proportion of patients that are using the braces
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Proportion of patients that are using the braces
Time Frame: 6 months follow up
brace usage, days per week
Change in Pain status compared to baseline
Time Frame: 1 year follow up
KOOS-12
Change in Mobility compared to baseline
Time Frame: 1 year follow up
KOOS-12
Proportion of patients that are still using the braces
Time Frame: 1 year follow up
brace usage, days per week
Sick leave after receiving the braces
Time Frame: 1 year follow up
Proportion of sick leave
Changes in reported quality of life
Time Frame: 1 year follow up
KOOS-12
Changes in QALY's
Time Frame: 1 year follow up
EQ-5D-5L
Secondary Outcomes
No secondary outcomes reported