Status:
COMPLETED
Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Osteoarthritis
Eligibility:
All Genders
45-75 years
Phase:
NA
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. ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00350896
Start Date
December 1 2003
End Date
December 1 2005
Last Update
July 11 2006
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