Ignite Creation Date:
2024-05-06 @ 3:30 PM
Last Modification Date:
2024-10-26 @ 1:50 PM
Study NCT ID:
NCT04651673
Status:
RECRUITING
Last Update Posted:
2022-04-20
First Post:
2020-11-18
Brief Title:
Prescribed Knee Brace Treatments for Osteoarthritis of the Knee Knee OA
Sponsor:
Össur Ehf
Organization:
Össur Ehf
Study Overview
Official Title:
Behandlingseffekter Med Avlastande knäortoser för Patienter Med knäartros En Retro-och Prospektiv Multicenterregisterstudie
Status:
RECRUITING
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None