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

Knee Osteoarthritis Clinical Trial

Official title:

Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04651673
• Other study ID #: CIP2020050839
• Status: Recruiting
• Start date: September 9, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: April 2022
• Source: Össur Ehf
• Contact: Karolin Lindgren Westlund
• Phone: +46-70-3573611
• Email: kalindgren[@]ossur.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• This is a non interventional registry
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.

Locations

Country	Name	City	State
Sweden	Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm	Hässleholm	Skåne

Sponsors (2)

Lead Sponsor	Collaborator
Össur Ehf	Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The patients' satisfaction of the value/effectiveness of the brace	Numeric Rating Scale (NRS) for satisfaction (0-10)	6 months follow up
Other	The patients' satisfaction of the value/effectiveness of the brace	NRS for satisfaction (0-10)	1 year follow up
Primary	Proportion of patients that are using the braces	brace usage, days per week	6 months follow up
Primary	Change in Pain status compared to baseline	Knee injury and Osteoarthritis Outcome Score (KOOS)-12	6 months follow up
Primary	Change in Mobility compared to baseline	KOOS-12	6 months follow up
Primary	Proportion of patients that are still using the braces	brace usage, days per week	1 year follow up
Primary	Change in Pain status compared to baseline	KOOS-12	1 year follow up
Primary	Change in Mobility compared to baseline	KOOS-12	1 year follow up
Primary	Sick leave after receiving the braces	Proportion of sick leave	6 months follow up
Primary	Sick leave after receiving the braces	Proportion of sick leave	1 year follow up
Primary	Changes in reported quality of life	KOOS-12	6 months follow up
Primary	Changes in reported quality of life	KOOS-12	1 year follow up
Primary	Changes in QALY's	EQ-5D-5L	6 months follow up
Primary	Changes in QALY's	EQ-5D-5L	1 year follow up