NCT05992883

NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis

NSAID Injection Versus Corticosteroid Injection for Basilar Thumb Arthritis: A Randomized, Controlled Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

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 of this disease. Despite its prevalence and previous research on treatments for the disease, there is a dearth of efficacious and low-cost interventions for trapeziometacarpal arthritis. Of these nonoperative interventions, intraarticular corticosteroid injections are the most popular and have the most evidence indicating their benefit. However, long-term use of corticosteroids has a well-established degenerative effect that is counterproductive to preserving cartilage and bone of the CMC joint. Novel, disease-modifying osteoarthritis treatments such as platelet rich plasma and human recombinant bone morphogenic protein 7, among others, are alternative options for patients. Many of these are currently in advanced development, but to date none have achieved FDA approval, and all are significantly more expensive and have limited availability compared to intraarticular corticosteroids. Although used infrequently, non-steroidal anti-inflammatory drugs (NSAIDs) are another modality of nonoperative intervention for basilar thumb arthritis. Intraarticular injections of NSAIDs have demonstrated success in alleviating the symptoms of primary arthritis in the hip and knee without concern of systemic side effects compared to oral NSAID use. Additionally, injectable NSAIDs are significantly more cost-effective compared to other injectables and do not have the chondrotoxic profile of corticosteroids. However, there are few studies directly comparing intraarticular NSAID use to other injectable therapies. Given the potential clinical and economic benefits of injectable NSAID therapy, we propose a clinical trial investigation examining the efficacy of intraarticular ketorolac versus intraarticular triamcinolone in treating symptoms of moderate to advanced primary osteoarthritis of the basilar thumb. The prospect of successfully alleviating symptoms of joint degeneration without propagating the progression of disease would be invaluable to the thousands of patients in the Mayo Clinic system and elsewhere afflicted with basilar thumb arthritis without the means or ability to pursue stem cell therapeutics or more definitive, operative intervention.

Conditions

• Thumb Osteoarthritis

Interventions

Type	Name	Description
DRUG	Ketorolac	Intervention will be an injection containing 1.0 mL of ketorolac 15 mg/mL (15 mg total of ketorolac).
DRUG	Triamcinolone	Intervention will be an injection containing 0.5 mL of triamcinolone 40 mg/mL (20 mg total of triamcinolone).

Timeline

• Start date: 2023-07-28
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-08-15
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study