NCT04651673|Recruiting
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee (Knee OA)
Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
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Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
Sponsor study identifier
observational
1,500
1 country
1
Study Start
September 9, 2020
Actual (reported)Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 9, 2020
Actual (reported)November 18, 2020
Actual (reported)December 3, 2020
Actual (reported)December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
The patients' satisfaction of the value/effectiveness of the brace
6 months follow up
The patients' satisfaction of the value/effectiveness of the brace
1 year follow up
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Skånevård Nordost Region Skåne - Verksamhets område ortopedi, Kristianstad /Hässleholm
Hässleholm, Skåne County, Sweden
Samuel Dencker, Dr
Region Skane
First Submitted
November 18, 2020
First Posted
December 3, 2020
Study Start
September 9, 2020
Actual (reported)Primary Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Intra and Inter Reliability of 30 Seconds Chair Stand Test as Self-test for Patients With Knee Osteoarthritis.
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
Contact the study team to confirm eligibility.
Study Completion
December 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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