Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)
Comparative Study of the Efficacy of Thumb Orthoses in the Base of the Thumb (BTOA)
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2003
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
July 10, 2006
CompletedFirst Posted
Study publicly available on registry
July 11, 2006
CompletedJuly 11, 2006
January 1, 2006
July 10, 2006
July 10, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain at 1 month assessed on visual analog scale is the main outcome measure.
Secondary Outcomes (1)
Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main secondary outcome measures.
Interventions
Eligibility Criteria
You may qualify if:
- Pain at the base of the thumb 30 mm on VAS
- Patient aged 45 and \< 75 years old
- At least 2 of the 5 items on the trapeziometacarpal joint radiograph osteophytes
- joint space narrowing
- subchondral bone sclerosis
- subchondral cysts
- At least 1 of the 2 clinical items trapeziometacarpal joint enlargement closure of the first web
You may not qualify if:
- Post traumatic osteoarthritis
- Cristal arthropathy
- Inflammatory arthritis
- Neurologic disorder involving upper limb
- Psychiatric disorder needing treatment adaptation in the last 3 months
- Hand or wrist trauma within the last 2 months
- Previous hand surgery
- Unable to speak or write French
- Pregnancy
- Collagen diseases (Dupuytren, Marfan, Ehlers Danlos syndromes)
- Hand or wrist infiltration within 2 months
- Skin disease interfering with the wearing of the orthoses
- Having already worn a BTOA orthoses
- Having bilateral BTOA without predominant symptomatic side
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Rannou F, Dimet J, Boutron I, Baron G, Fayad F, Mace Y, Beaudreuil J, Richette P, Ravaud P, Revel M, Poiraudeau S. Splint for base-of-thumb osteoarthritis: a randomized trial. Ann Intern Med. 2009 May 19;150(10):661-9. doi: 10.7326/0003-4819-150-10-200905190-00003.
PMID: 19451573DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Serge Poiraudeau, MD, Phd
Cochin Hospital AP-HP
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 10, 2006
First Posted
July 11, 2006
Study Start
December 1, 2003
Study Completion
December 1, 2005
Last Updated
July 11, 2006
Record last verified: 2006-01