Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350896
Status:
COMPLETED
Last Update Posted:
2006-07-11
First Post:
2006-07-10
Brief Title:
Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb BTOA
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb BTOA
Status:
COMPLETED
Status Verified Date:
2006-01
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:
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted
Interventions Thumb orthoses to be worn at night and usual care vs usual care Outcome measures Pain at 1 month assessed on visual analog scale is the main outcome measure Disability at 6 months Cochin Hand Function Scale and deformation at 1 year are the main secondary outcome measures
Interventions Thumb orthoses to be worn at night and usual care vs usual care Outcome measures Pain at 1 month assessed on visual analog scale is the main outcome measure Disability at 6 months Cochin Hand Function Scale and deformation at 1 year are the main secondary outcome measures
Detailed Description:
The prevalence of digital osteoarthritis varies according to whether a radiological or clinical definition is adopted Radiologically defined osteoarthritis of the hand has been estimated to represent 38 of women and 245 of men over 66 years of age but higher prevalence of 60-70 has also been reported Of patients with radiological signs 20 to 40 become symptomatic For patients over 55 years of age the distal interphalangeal joints are the most prevalent site of osteoarthritis 20 determined radiologically and clinically followed by the base of the thumb 8 and proximal interphalangeal joints 5 This prevalence increases with age and the incidence peaks in perimenopausal women Osteoarthritis in the base of the thumb BTOA concerns the trapeziometacarpal joint with a possible secondary location at the trapezotrapezoidial and scaphotrapezial joints BTOA induces a closure of the first web which in turn causes an alteration of the thumb-index pinch and therefore a limitation in hand function Pain induced by the compression of the thumb column during pinching could also lead to functional disability Effect of a simple intervention such as wearing rest thumb orthoses on pain and disability is unknown
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None