NCT04651673

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Sep 2020Dec 2030

Study Start

First participant enrolled

September 9, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
10.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

August 11, 2025

Status Verified

August 1, 2025

Enrollment Period

10.3 years

First QC Date

November 18, 2020

Last Update Submit

August 6, 2025

Conditions

Knee Osteoarthritis

Keywords

knee braceconservative treatment

Outcome Measures

Primary Outcomes (12)

  • 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 Outcomes (2)

  • 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

Interventions

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients that are prescribed knee brace for symptomatic treatment of knee OA from partaking clinics
  • Older than 18 years

You may not qualify if:

  • Younger than 18 years
  • Not willing or able to sign informed consent, or not cognitive impairments preventing understanding of the questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Hässleholm, Skåne County, Sweden

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Samuel Dencker, Dr

    Region Skåne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2020

First Posted

December 3, 2020

Study Start

September 9, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

August 11, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)