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

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ClinicalTrials.gov Identifier: NCT02612272
Recruitment Status : Unknown
Verified October 2016 by Paul Morton, MD, St. Luke's Hospital, Pennsylvania.
Recruitment status was:  Recruiting
First Posted : November 23, 2015
Last Update Posted : October 13, 2016
Sponsor:
Information provided by (Responsible Party):
Paul Morton, MD, St. Luke's Hospital, Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Ketorolac Drug: Betamethasone Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Controlled, Equivalence Study Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections
Study Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017


Arm Intervention/treatment
Active Comparator: Corticosteroid

This arm will receive intra-articular betamethasone.

4cc of 1% lidocaine, 1cc of 0.9% normal saline and 1cc (6 mg) of betamethasone.

An 18 gauge needle connected to a syringe filled with the study drug will be administered. If there is no effusion, a 22 gauge needle with 6cc of the study drug will be injected into the administration site

Please see detailed description of study for further information.

Drug: Betamethasone
intra-articular betamethasone
Other Name: Celestone

Experimental: Ketorolac

This arm will receive intra articular ketorolac.

2cc (60 mg) of ketorolac and 4cc of 1% lidocaine

An 18 gauge needle connected to a syringe filled with the study drug will be administered. If there is no effusion, a 22 gauge needle with 6cc of the study drug will be injected into the administration site

Please see detailed description of study for further information.

Drug: Ketorolac
intra-articular ketorolac
Other Name: toradol




Primary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Follow up at 1 month ]
    Determination of patient's function and pain following intra-articular drug administration


Secondary Outcome Measures :
  1. Knee injury and Osteoarthritis Outcome Score score [ Time Frame: Follow up at 1, 3 and 6 months ]
    Determination of patient's function and pain following intra-articular drug administration

  2. Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL) scale [ Time Frame: Follow up at 1, 3 and 6 months ]
    Determination of patient's function and pain following intra-articular drug administration

  3. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Follow up at 3 months ]
    Determination of patient's function and pain following intra-articular drug administration

  4. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Follow up at 6 months ]
    Determination of patient's function and pain following intra-articular drug administration



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Knee osteoarthritis as demonstrated on x-ray as Kellgren-Lawrence stage II or higher (Kellgren & Lawrence, 1957)
  • Clinical symptoms and physical exam consistent with osteoarthritis

Exclusion Criteria:

  • Prior treatment with corticosteroid injections within the last 1 year
  • Failure of past treatment with corticosteroid injections
  • Medical treatment including oral medication, physical therapy, or other analgesia use within the last 20 days prior to injection
  • Pregnant
  • Under 18
  • Serious systemic disease
  • Gout arthropathy
  • Inflammatory joint disease including rheumatoid or psoriatic arthritis
  • Metabolic bone disease
  • Anserine bursitis or pain referred from other structures such as ipsilateral hip or lumbar spine
  • Patients with a significant effusion that requires aspiration

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612272


Contacts
Contact: Paul Morton, MD 8082538696 mortonp@slhn.org

Locations
United States, Pennsylvania
St Luke's Health and University Network Recruiting
Bethlehem, Pennsylvania, United States, 18018
Contact: Manny Changalis, MS, CIP    484-526-4944    manny.changalis@sluhn.org   
Sub-Investigator: Paul Morton, MD         
Principal Investigator: Gregory Carolan, MD         
Sub-Investigator: Shane McGowan, MD         
Sponsors and Collaborators
St. Luke's Hospital, Pennsylvania
Investigators
Principal Investigator: Gregory Carolan, MD St Luke's Health University Network

Publications:

Responsible Party: Paul Morton, MD, Orthopaedic Surgery Resident, St. Luke's Hospital, Pennsylvania
ClinicalTrials.gov Identifier: NCT02612272     History of Changes
Other Study ID Numbers: SLHN 2015-40
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: October 13, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will plan to submit to orthopaedic journals for publication

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Respiratory System Agents