Knee Injection RCT

February 5, 2020 updated by: UConn Health

Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to examine the effectiveness of intra-articular (inside the joint) ketorolac injection compared to injection with either corticosteroid or hyaluronic acid for the treatment of painful knee osteoarthritis. Patients will be randomly assigned to receive either ketorolac (a nonsteroidal anti-inflammatory drug, methylprednisolone (a steroid), hyaluronic acid (a substance that is naturally present in the human body).

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • UConn Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief.

Exclusion Criteria:

  • Prior injections into the same knee within the past 6 months,
  • Pregnant and/or lactating women,
  • Inflammatory joint disease including rheumatoid or psoriatic arthritis,
  • Concurrent use of anti-rheumatic drugs,
  • Allergy or hypersensitivity to the study medications,
  • Patients on an active pain management contract,
  • Patients with insurance that requires pre-certification for any of the study drugs,
  • Inability to make own decisions regarding the informed consent,
  • Inability to read and/or understand English,
  • Patients who are unable to return for follow-up or be reached by phone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ketorolac
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Drug: Ketorolac Tromethamine Injection
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Other Names:
  • Ketorolac Tromethamine; NDC 63323-162-02; J Code J1885
ACTIVE_COMPARATOR: Corticosteroid
One knee injection of 2 cc of methylprednisolone acetate (40mg/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
Other Names:
  • DEPO-MEDROL; NDC 0009-3073-01; J Code J1030
ACTIVE_COMPARATOR: Hyaluronic Acid
One knee injection of Hylan G-F 20 (Synvisc-One)
Drug: Hylan G-F 20
One knee injection of Hylan G-F 20 (Synvisc-One)
Other Names:
  • Synvisc-One; NDC 58468-0090-03; J Code J7325

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Pain Scale (VAS)
Time Frame: 3 months post injection
average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection
3 months post injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame: 3 and 6 months post injection
self-reported pain, stiffness and functioning
3 and 6 months post injection
Oxford Knee Questionnaire
Time Frame: 3 and 6 months post injection
self-reported pain, stiffness and functioning
3 and 6 months post injection
Koos, Jr. Knee Survey
Time Frame: 3 and 6 months post injection
self-reported pain, stiffness and functioning
3 and 6 months post injection
Visual Analogue Pain Scale (VAS)
Time Frame: 6 months
average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection
6 months
Patient Satisfaction
Time Frame: 3 and 6 months post injection
satisfaction with treatment rated as "Yes" or "No"
3 and 6 months post injection
Non-routine Visits Due to Inadequate Pain Relief or Complications
Time Frame: 3 months post injection
Any additional visits due to inadequate pain relief or complications
3 months post injection
Cost of Intervention
Time Frame: 3 months post injection
cost of each injection
3 months post injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

Orthopedic Research and Education Foundation

Investigators

  • Principal Investigator: Mohamad J. Halawi, MD, UConn Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 5, 2018

Primary Completion (ACTUAL)

July 16, 2019

Study Completion (ACTUAL)

July 16, 2019

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

October 1, 2018

First Posted (ACTUAL)

October 3, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 18, 2020

Last Update Submitted That Met QC Criteria

February 5, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-093-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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