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Knee Injection RCT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03694821
Recruitment Status : Terminated (Low enrollment)
First Posted : October 3, 2018
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Collaborator:
Orthopedic Research and Education Foundation
Information provided by (Responsible Party):
UConn Health

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.


Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Ketorolac Tromethamine Injection Drug: Methylprednisolone Acetate Injection Drug: Hylan G-F 20 Phase 4

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study
Actual Study Start Date : July 5, 2018
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019


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 Name: 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 Name: 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 Name: Synvisc-One; NDC 58468-0090-03; J Code J7325




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: 3 and 6 months post injection ]
    self-reported pain, stiffness and functioning

  2. Oxford Knee Questionnaire [ Time Frame: 3 and 6 months post injection ]
    self-reported pain, stiffness and functioning

  3. Koos, Jr. Knee Survey [ Time Frame: 3 and 6 months post injection ]
    self-reported pain, stiffness and functioning

  4. Visual Analogue Pain Scale (VAS) [ Time Frame: 6 months ]
    average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection

  5. Patient Satisfaction [ Time Frame: 3 and 6 months post injection ]
    satisfaction with treatment rated as "Yes" or "No"

  6. 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

  7. Cost of Intervention [ Time Frame: 3 months post injection ]
    cost of each injection



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT03694821


Locations
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United States, Connecticut
UConn Health
Farmington, Connecticut, United States, 06032
Sponsors and Collaborators
UConn Health
Orthopedic Research and Education Foundation
Investigators
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Principal Investigator: Mohamad J. Halawi, MD UConn Health
  Study Documents (Full-Text)

Documents provided by UConn Health:
Publications:
Bone and Joint Initiative: The Burden of Musculoskeletal Diseases in the United States. http://www.boneandjointburden.org/2014-report/ivh12/osteoarthritis-and-allied-disorders

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Responsible Party: UConn Health
ClinicalTrials.gov Identifier: NCT03694821    
Other Study ID Numbers: 18-093-1
First Posted: October 3, 2018    Key Record Dates
Results First Posted: February 18, 2020
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UConn Health:
Osteoarthritis
Knee
Injection
Ketorolac
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Ketorolac
Ketorolac Tromethamine
Prednisolone hemisuccinate
Prednisolone phosphate
Hylan
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic