Ensayos clínicos

Inclusion Criteria: 

• 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 with oral analgesics, NSAIDs, icing, and splinting.
• 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 Criteria: 

• Known allergy to either of the treatment products.
• Patient’s analgesic treatment regimen was modified within four weeks before trial inclusion.
• 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.
• 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.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/19/23. Questions regarding updates should be directed to the study team contact.