Knee Injection RCT

Sponsor
UConn Health (Other)
Overall Status
Terminated
CT.gov ID
NCT03694821
Collaborator
Orthopedic Research and Education Foundation (Other)
18
Enrollment
1
Location
3
Arms
12.4
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • 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).

Study Design

Study Type:
Interventional
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 :
Jul 5, 2018
Actual Primary Completion Date :
Jul 16, 2019
Actual Study Completion Date :
Jul 16, 2019

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Visual Analogue Pain Scale (VAS) [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) [3 and 6 months post injection]

      self-reported pain, stiffness and functioning

    2. Oxford Knee Questionnaire [3 and 6 months post injection]

      self-reported pain, stiffness and functioning

    3. Koos, Jr. Knee Survey [3 and 6 months post injection]

      self-reported pain, stiffness and functioning

    4. Visual Analogue Pain Scale (VAS) [6 months]

      average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection

    5. Patient Satisfaction [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 [3 months post injection]

      Any additional visits due to inadequate pain relief or complications

    7. Cost of Intervention [3 months post injection]

      cost of each injection

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1UConn HealthFarmingtonConnecticutUnited States06032

    Sponsors and Collaborators

    • UConn Health
    • Orthopedic Research and Education Foundation

    Investigators

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

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    UConn Health
    ClinicalTrials.gov Identifier:
    NCT03694821
    Other Study ID Numbers:
    • 18-093-1
    First Posted:
    Oct 3, 2018
    Last Update Posted:
    Feb 18, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by UConn Health
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Period Title: Overall Study
    STARTED486
    COMPLETED002
    NOT COMPLETED484

    Baseline Characteristics

    Arm/Group TitleKetorolacCorticosteroidHyaluronic AcidTotal
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)Total of all reporting groups
    Overall Participants48618
    Age (Count of Participants)
    <=18 years
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Between 18 and 65 years
    4
    100%
    6
    75%
    4
    66.7%
    14
    77.8%
    >=65 years
    0
    0%
    2
    25%
    2
    33.3%
    4
    22.2%
    Sex: Female, Male (Count of Participants)
    Female
    2
    50%
    5
    62.5%
    4
    66.7%
    11
    61.1%
    Male
    2
    50%
    3
    37.5%
    2
    33.3%
    7
    38.9%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    1
    25%
    1
    12.5%
    1
    16.7%
    3
    16.7%
    Not Hispanic or Latino
    3
    75%
    7
    87.5%
    5
    83.3%
    15
    83.3%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Asian
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    3
    37.5%
    1
    16.7%
    4
    22.2%
    White
    3
    75%
    4
    50%
    4
    66.7%
    11
    61.1%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    1
    25%
    1
    12.5%
    1
    16.7%
    3
    16.7%

    Outcome Measures

    1. Primary Outcome
    TitleVisual Analogue Pain Scale (VAS)
    Descriptionaverage knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection
    Time Frame3 months post injection

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000
    2. Secondary Outcome
    TitleWestern Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
    Descriptionself-reported pain, stiffness and functioning
    Time Frame3 and 6 months post injection

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000
    3. Secondary Outcome
    TitleOxford Knee Questionnaire
    Descriptionself-reported pain, stiffness and functioning
    Time Frame3 and 6 months post injection

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000
    4. Secondary Outcome
    TitleKoos, Jr. Knee Survey
    Descriptionself-reported pain, stiffness and functioning
    Time Frame3 and 6 months post injection

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000
    5. Secondary Outcome
    TitleVisual Analogue Pain Scale (VAS)
    Descriptionaverage knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection
    Time Frame6 months

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000
    6. Secondary Outcome
    TitlePatient Satisfaction
    Descriptionsatisfaction with treatment rated as "Yes" or "No"
    Time Frame3 and 6 months post injection

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000
    7. Secondary Outcome
    TitleNon-routine Visits Due to Inadequate Pain Relief or Complications
    DescriptionAny additional visits due to inadequate pain relief or complications
    Time Frame3 months post injection

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000
    8. Secondary Outcome
    TitleCost of Intervention
    Descriptioncost of each injection
    Time Frame3 months post injection

    Outcome Measure Data

    Analysis Population Description
    Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Methylprednisolone Acetate Injection: One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)
    Measure Participants000

    Adverse Events

    Time Frame12 months
    Adverse Event Reporting Description Same definition was used.
    Arm/Group TitleKetorolacCorticosteroidHyaluronic Acid
    Arm/Group DescriptionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrineOne knee injection of Hylan G-F 20 (Synvisc-One)
    All Cause Mortality
    KetorolacCorticosteroidHyaluronic Acid
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/4 (0%) 0/8 (0%) 0/6 (0%)
    Serious Adverse Events
    KetorolacCorticosteroidHyaluronic Acid
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total0/4 (0%) 0/8 (0%) 0/6 (0%)
    Other (Not Including Serious) Adverse Events
    KetorolacCorticosteroidHyaluronic Acid
    Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
    Total1/4 (25%) 0/8 (0%) 0/6 (0%)
    Gastrointestinal disorders
    Stomach ache1/4 (25%) 10/8 (0%) 00/6 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleDirector of Outcomes, Research & Quality
    OrganizationUConn Health
    Phone860-679-4932
    Emailmcote@uchc.edu
    Responsible Party:
    UConn Health
    ClinicalTrials.gov Identifier:
    NCT03694821
    Other Study ID Numbers:
    • 18-093-1
    First Posted:
    Oct 3, 2018
    Last Update Posted:
    Feb 18, 2020
    Last Verified:
    Feb 1, 2020