Knee Injection RCT

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Mohamad Halawi，UConn Health

Tracking Information

First Submitted Date ^ICMJE

August 16, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

July 5, 2018

Estimated Primary Completion Date

February 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual Analogue Pain Scale (VAS)[ Time Frame: 3 months post injection ]

average knee pain 3 months following injection

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)[ Time Frame: 3 and 6 months post injection ]
self-reported pain, stiffness and functioning
Oxford Knee questionnaire[ Time Frame: 3 and 6 months post injection ]
self-reported pain, stiffness and functioning
Koos, Jr. Knee Survey[ Time Frame: 3 and 6 months post injection ]
self-reported pain, stiffness and functioning
Visual Analogue Pain Scale (VAS)[ Time Frame: 6 months ]
average knee pain 6 months following injection
Patient Satisfaction[ Time Frame: 3 and 6 months post injection ]
satisfaction with treatment rated as "Yes" or "No"
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
Cost of Intervention[ Time Frame: 3 months post injection ]
cost of each injection

Descriptive Information

Brief Title ^ICMJE

Knee Injection RCT

Official Title ^ICMJE

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

Brief 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.

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 ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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)

Study Arms

Experimental: Ketorolac
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Active Comparator: Corticosteroid
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Active Comparator: Hyaluronic Acid
One knee injection of Hylan G-F 20 (Synvisc-One)

Recruitment Information

Recruitment Status ^ICMJE

Enrolling by invitation

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

February 2019

Estimated Primary Completion Date

February 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Mohamad Halawi，UConn Health

Study Sponsor ^ICMJE

UConn Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Mohamad J. Halawi, MD UConn Health

PRS Account

UConn Health

Verification Date

August 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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