Knee OsteoarthritisNCT04651673
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
An observational study of Knee Osteoarthritis, run by Össur Iceland ehf at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- This is a non interventional registry
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 9 Sep 2020to 31 Dec 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- Patients that are prescribed knee brace for symptomatic treatment of knee OA from partaking clinics
- Older than 18 years
Who cannot join
- Younger than 18 years
- Not willing or able to sign informed consent, or not cognitive impairments preventing understanding of the questionnaires.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm
Hässleholm, Skåne County
Samuel Dencker, Dr
Tobias Berlin, +46 451 296471, Tobias.Berlin@skane.se
About this study
Official title: Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
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.
Read the 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.
- Conditions
- Knee Osteoarthritis
- Being tested
- This is a non interventional registry
- Keywords
- knee brace, conservative treatment
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is a non interventional registryOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that are using the braces
brace usage, days per week
Measured: 6 months follow up
Change in Pain status compared to baseline
Knee injury and Osteoarthritis Outcome Score (KOOS)-12
Measured: 6 months follow up
Change in Mobility compared to baseline
KOOS-12
Measured: 6 months follow up
Proportion of patients that are still using the braces
brace usage, days per week
Measured: 1 year follow up
Change in Pain status compared to baseline
KOOS-12
Measured: 1 year follow up
Change in Mobility compared to baseline
KOOS-12
Measured: 1 year follow up
Sick leave after receiving the braces
Proportion of sick leave
Measured: 6 months follow up
Sick leave after receiving the braces
Proportion of sick leave
Measured: 1 year follow up
Changes in reported quality of life
KOOS-12
Measured: 6 months follow up
Changes in reported quality of life
KOOS-12
Measured: 1 year follow up
Changes in QALY's
EQ-5D-5L
Measured: 6 months follow up
Changes in QALY's
EQ-5D-5L
Measured: 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start9 Sep 2020
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Össur Iceland ehf
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Region Skane
- Responsible party
- Sponsor
- Investigators
- Samuel Dencker, Dr, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651673
- Sponsor's protocol ID
- CIP2020050839
- Status last verified
- Oct 2026
- First submitted
- 18 Nov 2020
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
- ClinicalTrials.gov ID
- NCT04651673
- Acronym / sponsor ID
- CIP2020050839
- Conditions
- Knee Osteoarthritis
- Keywords
- knee brace, conservative treatment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Össur Iceland ehfIndustry (pharma, biotech, devices)
- Collaborators
- Region Skane
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (2 listed)
- Patients that are prescribed knee brace for symptomatic treatment of knee OA from partaking clinics
- Older than 18 years
Key exclusion criteria (2 listed)
- Younger than 18 years
- Not willing or able to sign informed consent, or not cognitive impairments preventing understanding of the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is a non interventional registryAll 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. | Other | – |
Primary outcome
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: 6 months follow up
Knee injury and Osteoarthritis Outcome Score (KOOS)-12
Change in Mobility compared to baseline
Time frame: 6 months follow up
KOOS-12
Proportion of patients that are still using the braces
Time frame: 1 year 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
Sick leave after receiving the braces
Time frame: 6 months follow up
Proportion of sick leave
Sick leave after receiving the braces
Time frame: 1 year follow up
Proportion of sick leave
Changes in reported quality of life
Time frame: 6 months follow up
KOOS-12
Changes in reported quality of life
Time frame: 1 year follow up
KOOS-12
Changes in QALY's
Time frame: 6 months follow up
EQ-5D-5L
Changes in QALY's
Time frame: 1 year follow up
EQ-5D-5L
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Samuel Dencker, Dr principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Össur Iceland ehf at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karolin Lindgren Westlund (+46-70-3573611, kalindgren@ossur.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that are using the braces (time frame: 6 months follow up). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.