Knee Injection RCT
NCT03694821 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2020-02-18
Summary
Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (OA) compared to steroids and viscosupplementation.
Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in the nonsurgical management of symptomatic OA compared to injections with corticosteroids and viscosupplements.
Conditions
Interventions
- DRUG
-
Ketorolac Tromethamine Injection
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
- DRUG
-
Methylprednisolone Acetate Injection
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
- DRUG
-
Hylan G-F 20
One knee injection of Hylan G-F 20 (Synvisc-One)
Sponsors & Collaborators
-
Orthopedic Research and Education Foundation
collaborator OTHER -
UConn Health
lead OTHER
Principal Investigators
-
Mohamad J. Halawi, MD · UConn Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-07-05
- Primary Completion
- 2019-07-16
- Completion
- 2019-07-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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