Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06204471
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-11-14
Brief Title:
Acceptability of Hip Protector Airbags in Older People
Sponsor:
Royal College of Surgeons Ireland
Organization:
Royal College of Surgeons Ireland
Study Overview
Official Title:
Evaluating the Acceptability of Airbag Hip Protectors in Older People
Status:
RECRUITING
Status Verified Date:
2024-01
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:
Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable
Detailed Description:
Traditional hip protectors are specialised pads designed to shield the greater trochanter on fall impact They have uncertain benefits in reducing hip fracture risk and have very poor uptake due to discomfort Recently airbag technology has allowed radical change in design and wearability of hip protectors Despite these airbags being commercially available there is little evidence of their acceptabilitywearability and as with all hip protectors virtually no research exists in community-dwelling people A study of traditional hip protectors found that they may reduce fear of falling FoF in community dwellers but activity levels or quality of life were not assessed A non-randomised study is ongoing of hip airbags on fractures in nursing homes but none in community dwellers Two Hip Protectors available in Europe are CE marked as personal protective equipment and approved for sale There is a need to evaluate their acceptability and usefulness before considering larger clinical trials evaluating their efficacy in preventing hip fractures This study will evaluate the two hip protectors and gain patient feedback in their use
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