Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: This is a non interventional registry

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 Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Hässleholm, Skåne, Sweden
      • Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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	NRS for satisfaction (0-10)	1 year follow up

Collaborators and Investigators

• Sponsor: Össur Iceland ehf
• Collaborators: Region Skane
• Investigators: Principal Investigator: Samuel Dencker, Dr, Region Skane

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 18, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: conservative treatment; knee brace
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: CIP2020050839

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No