Status:
RECRUITING
NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis
Lead Sponsor:
Mayo Clinic
Conditions:
Thumb Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
The Researchers are trying to compare two different types of intraarticular injections (injection in the joint) for treating the symptoms of moderate to advanced basilar thumb arthritis. One injection...
Detailed Description
Cartilage degeneration resulting in osteoarthritis is the most common and costly musculoskeletal disorder in the United States, with basilar thumb arthritis being one of the most common manifestations...
Eligibility Criteria
Inclusion
- Adults \>40 years of age
- Pain at the thumb base brought on by direct pressure (grind test) and with movement
- Pain resistant to previous conservative management (including over the counter medications (ibuprofen/acetaminophen), icing, splinting/braces, or topical analgesics)
- Radiological observation indicative of arthritis based on the Eaton-Littler classification system (stages 1 through 4)
- Patient understands the protocol and signed the informed consent
- Patient is covered by health insurance
Exclusion
- • Known allergy to either of the treatment products
- Patient's analgesic treatment regimen or other modalities of managing symptoms/pain associated with their hand pathology was modified within four weeks before trial inclusion
- Symptomatic Scaphoid-trapezial arthritis present
- Localized or systemic infection
- Previous thumb surgery on study thumb
- Previous thumb injury on study thumb
- Patient with inflammatory arthritis (e.g., rheumatoid arthritis, psoriatic arthritis)
- Severe and/or uncontrolled hypertension
- De Quervain tendinopathy present
- History of injection to the trapeziometacarpal joint on study thumb within the previous 6 weeks
- Uncontrolled diabetes
- Pregnant or lactating females. Female participants of childbearing potential must have a negative pregnancy test before the injection. Women without childbearing potential (ie., surgically sterile with hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy OR ≥ 12 months of amenorrhea and at least 50 years of age) are eligible to participate without completing a pregnancy test.
- Immunodeficient patients
- Patients that are currently using nicotine products, or who have quit in the last 12 months
- Patients under guardianship, curatorship, or are otherwise not self-sufficient
- Patients participating in another clinical research trial which interferes with this study protocol or outcomes
- Patients unable to follow the protocol in the investigators' judgement.
Key Trial Info
Start Date :
July 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05992883
Start Date
July 28 2023
End Date
December 31 2025
Last Update
December 3 2025
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905