Knee Injection RCT

NCT03694821 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-02-18

Study results available
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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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03694821 on ClinicalTrials.gov