Overview

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

Status:
Unknown status
Trial end date:
2017-10-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
St. Luke's Hospital, Pennsylvania
Treatments:
Betamethasone
Betamethasone benzoate
Betamethasone sodium phosphate
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Ketorolac
Ketorolac Tromethamine