Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections

• Status: Unknown status
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: Male

Summary

This study will compare the efficacy of intra-articular betamethasone injection to intra-articular ketorolac injection for symptomatic treatment of knee osteoarthritis in an equivalence study using a double-blinded, randomized, controlled design. Patients will be recruited from orthopaedic clinics at St. Luke's University Health Network. A total of 448 patients will be recruited (224 in each group) to receive an administration of an intra-articular betamethasone or ketorolac injection. The primary outcome is change in pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes include Knee Injury and Osteoarthritis Outcome (KOOS) and Knee Outcome Survey - Activities of Daily Living (KOS-ADL) scores and physical exam findings. Statistical analyses include repeated measures analysis of variance (ANOVA) (primary outcome) and selected ANOVA and nonparametric tests as deemed appropriate (secondary outcomes), with p < .05 denoting significance for all comparisons, and no adjustment for multiple testing.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: St. Luke's Hospital, Pennsylvania
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Ketorolac; Ketorolac Tromethamine

Criteria

Inclusion Criteria:

• Knee osteoarthritis as demonstrated on x-ray as Kellgren-Lawrence stage II or higher (Kellgren & Lawrence, 1957)

• Clinical symptoms and physical exam consistent with osteoarthritis

Exclusion Criteria:

• Prior treatment with corticosteroid injections within the last 1 year

• Failure of past treatment with corticosteroid injections

• Medical treatment including oral medication, physical therapy, or other analgesia use within the last 20 days prior to injection

• Pregnant

• Under 18

• Serious systemic disease

• Gout arthropathy

• Inflammatory joint disease including rheumatoid or psoriatic arthritis

• Metabolic bone disease

• Anserine bursitis or pain referred from other structures such as ipsilateral hip or lumbar spine

• Patients with a significant effusion that requires aspiration