An observational study in Knee Osteoarthritis, sponsored by Össur Iceland ehf. Enrolling by invitation at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-08-11.
Sponsored by Össur Iceland ehf · Observational
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 1,500 is above the median of 100 across 472 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Össur Iceland ehf is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Proportion of patients that are using the braces
brace usage, days per week
Time frame: 6 months follow up
Change in Pain status compared to baseline
Knee injury and Osteoarthritis Outcome Score (KOOS)-12
Time frame: 6 months follow up
Change in Mobility compared to baseline
KOOS-12
Time frame: 6 months follow up
Proportion of patients that are still using the braces
brace usage, days per week
Time frame: 1 year follow up
Change in Pain status compared to baseline
KOOS-12
Time frame: 1 year follow up
Change in Mobility compared to baseline
KOOS-12
Time frame: 1 year follow up
Sick leave after receiving the braces
Proportion of sick leave
Time frame: 6 months follow up
Sick leave after receiving the braces
Proportion of sick leave
Time frame: 1 year follow up
Changes in reported quality of life
KOOS-12
Time frame: 6 months follow up
Changes in reported quality of life
KOOS-12
Time frame: 1 year follow up
Changes in QALY's
EQ-5D-5L
Time frame: 6 months follow up
Changes in QALY's
EQ-5D-5L
Time frame: 1 year follow up
The patients' satisfaction of the value/effectiveness of the brace
Numeric Rating Scale (NRS) for satisfaction (0-10)
Time frame: 6 months follow up
The patients' satisfaction of the value/effectiveness of the brace
NRS for satisfaction (0-10)
Time frame: 1 year follow up
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Össur Iceland ehf