NCT05992883 NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis
| NCT ID | NCT05992883 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Mayo Clinic |
| Condition | Thumb Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2023-07-28 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2023-07-28 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 is ketorolac (an NSAID) and the other is triamcinolone (a corticosteroid).
Eligibility Criteria
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 (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 Criteria: * • 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.
Contact & Investigator
Marco Rizzo, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT05992883 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Thumb Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05992883 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT05992883 currently recruiting?
Yes, NCT05992883 is actively recruiting participants. Contact the research team at hobbs.lindsey@mayo.edu for enrollment information.
Where is the NCT05992883 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT05992883 clinical trial?
NCT05992883 is sponsored by Mayo Clinic. The principal investigator is Marco Rizzo, MD at Mayo Clinic. The trial plans to enroll 240 participants.