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Liposomal Bupivacaine vs Dexamethasone ISB

Sponsor
Hospital for Special Surgery, New York (Other)
Overall Status
Completed
CT.gov ID
NCT04047446
Collaborator
(none)
112
Enrollment
1
Location
2
Arms
20.3
Actual Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial
Actual Study Start Date :
Jul 11, 2019
Actual Primary Completion Date :
Mar 15, 2021
Actual Study Completion Date :
Mar 19, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Liposomal bupivacaine & standard bupivacaine

Drug: Exparel 133 MG Per 10 ML Injection
10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
Other Names:
  • Liposomal Bupivacaine

    		•
    Active Comparator: Standard bupivacaine & dexamethasone

    Drug: Dexamethasone
    15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

    Outcome Measures

    Primary Outcome Measures

    1. Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours [First 72 hours pain]

      NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.

    Secondary Outcome Measures

    1. Numerical Rating Scale (NRS) Pain at Rest [Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7]

      NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.

    2. Numerical Rating Scale (NRS) Pain With Movement [Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7]

      NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.

    3. Opioid Consumption [Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7]

      Opioid consumption, measured in oral morphine equivalents

    4. Patient Satisfaction With Pain Management: Scale [Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7]

      Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction

    5. Brief Pain Inventory Short-form [Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7]

      The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.

    6. Duration of Analgesic Block [24, 48, 72, 96 (if needed) hours postoperatively]

      Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration.

    7. Sensory Resolution [24, 48, 72, 96 (if needed) hours postoperatively]

      Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

    8. Motor Block Resolution [24, 48, 72, 96 (if needed) hours postoperatively]

      Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

    9. Time to Readiness for Discharge [Postanesthesia care unit (0-6 hours postoperative)]

      Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.

    10. Postanesthesia Care Unit Length of Stay [Postanesthesia care unit (0-6 hours postoperative)]

      Total length of PACU stay as defined by time of PACU admission to PACU discharge.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • ASA I-III

    • Age 18 years or older

    • Scheduled for elective outpatient arthroscopic shoulder surgery

    Exclusion Criteria:

    • History of allergy to local anesthetic, or one of the study medications

    • Pre-existing neurological deficits

    • Psychiatric or cognitive disorders that prohibit patients from following study protocol

    • History of drug or alcohol abuse

    • Chronic opioid use (longer than 3 months)

    • Chronic pain syndromes

    • Infection at the site of injection

    • Patients with severe pulmonary disease

    • Herniated cervical disc, cervical myelopathy

    • Contraindication for general anesthesia and/or interscalene nerve block

    • Pregnancy

    • Open shoulder arthrotomies.

    • Non English speakers

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital for Special Surgery New York New York United States 10021

    Sponsors and Collaborators

    • Hospital for Special Surgery, New York

    Investigators

    • Principal Investigator: David Kim, MD, Hospital for Special Surgery, New York

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Hospital for Special Surgery, New York
    ClinicalTrials.gov Identifier:
    NCT04047446
    Other Study ID Numbers:
    • 2019-0424
    First Posted:
    Aug 6, 2019
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Additional relevant MeSH terms:
    Shoulder Pain
    Dexamethasone
    Bupivacaine

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Period Title: Overall Study
    STARTED 56 56
    COMPLETED 55 56
    NOT COMPLETED 1 0

    Baseline Characteristics

    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone Total
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected Total of all reporting groups
    Overall Participants 55 56 111
    Age (year) [Median (Inter-Quartile Range) ]
    Median (Inter-Quartile Range) [year]
    55
    49
    53
    Sex: Female, Male (Count of Participants)
    Female
    12
    21.8%
    8
    14.3%
    20
    18%
    Male
    43
    78.2%
    48
    85.7%
    91
    82%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    3.6%
    4
    7.1%
    6
    5.4%
    Not Hispanic or Latino
    52
    94.5%
    52
    92.9%
    104
    93.7%
    Unknown or Not Reported
    1
    1.8%
    0
    0%
    1
    0.9%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    2
    3.6%
    3
    5.4%
    5
    4.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    5
    9.1%
    5
    8.9%
    10
    9%
    White
    45
    81.8%
    46
    82.1%
    91
    82%
    More than one race
    0
    0%
    0
    0%
    0
    0%
    Unknown or Not Reported
    3
    5.5%
    2
    3.6%
    5
    4.5%
    Region of Enrollment (Count of Participants)
    United States
    55
    100%
    56
    100%
    111
    100%
    American Society of Anesthesiology Status (Count of Participants)
    ASA Status I
    10
    18.2%
    12
    21.4%
    22
    19.8%
    ASA status II
    45
    81.8%
    44
    78.6%
    89
    80.2%
    Body Mass Index, kg/m^2 (Kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kg/m^2]
    27.6
    (4.1)
    27.5
    (4.1)
    27.6
    (4.1)

    Outcome Measures

    1. Primary Outcome
    Title Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
    Description NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.
    Time Frame First 72 hours pain

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Mean (Standard Deviation) [score on a scale]
    2.4
    (1.9)
    3.4
    (1.9)
    2. Secondary Outcome
    Title Numerical Rating Scale (NRS) Pain at Rest
    Description NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.
    Time Frame Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Postanesthesia care unit (0-6 hours postoperative)
    1.3
    (1.9)
    0.9
    (1.8)
    Postoperative day 1
    2.1
    (2.6)
    3.0
    (2.5)
    Postoperative day 2
    2.5
    (2.3)
    4.1
    (2.7)
    Postoperative day 3
    2.4
    (2.2)
    3.3
    (2.4)
    Postoperative day 4
    2.5
    (2.0)
    3.0
    (2.2)
    Postoperative day 7
    1.7
    (2.0)
    2.3
    (2.2)
    3. Secondary Outcome
    Title Numerical Rating Scale (NRS) Pain With Movement
    Description NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.
    Time Frame Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Postanesthesia care unit (0-6 hours postoperative)
    8.9
    (4.3)
    9.98
    (3.2)
    Postoperative day 1
    4.0
    (3.1)
    4.3
    (3.1)
    Postoperative day 2
    4.1
    (2.9)
    5.6
    (3.1)
    Postoperative day 3
    4.0
    (2.7)
    5.3
    (2.3)
    Postoperative day 4
    4.0
    (2.8)
    4.9
    (2.4)
    Postoperative day 7
    3.9
    (2.6)
    4.7
    (2.5)
    4. Secondary Outcome
    Title Opioid Consumption
    Description Opioid consumption, measured in oral morphine equivalents
    Time Frame Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Postanesthesia care unit (0-6 hours postoperative)
    1.8
    (4.5)
    1.7
    (4.6)
    Postoperative day 1
    4.8
    (8.6)
    8.1
    (10.4)
    Postoperative day 2
    12.3
    (15.6)
    18.2
    (20.8)
    Postoperative day 3
    8.9
    (12.5)
    13.2
    (14.0)
    Postoperative day 4
    6.9
    (13.8)
    9.7
    (15.5)
    Postoperative day 7
    3.7
    (7.4)
    3.3
    (7.2)
    5. Secondary Outcome
    Title Patient Satisfaction With Pain Management: Scale
    Description Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction
    Time Frame Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Postanesthesia care unit (0-6 hours postoperative)
    9.4
    (1.3)
    9.8
    (0.5)
    Postoperative day 1
    9.3
    (1.4)
    9.2
    (1.6)
    Postoperative day 2
    8.9
    (2.1)
    8.6
    (1.8)
    Postoperative day 3
    9.2
    (1.4)
    8.6
    (1.7)
    Postoperative day 4
    9.1
    (1.2)
    8.5
    (1.7)
    Postoperative day 7
    9.1
    (1.5)
    8.4
    (2.1)
    6. Secondary Outcome
    Title Brief Pain Inventory Short-form
    Description The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.
    Time Frame Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Postanesthesia care unit (0-6 hours postoperative)
    1.2
    (2.0)
    0.6
    (1.4)
    Postoperative day 1
    1.4
    (2.0)
    1.8
    (2.3)
    Postoperative day 2
    2.4
    (2.3)
    3.6
    (2.5)
    Postoperative day 3
    2.2
    (2.0)
    3.4
    (2.1)
    Postoperative day 4
    2.5
    (2.3)
    3.6
    (2.1)
    Postoperative day 7
    2.2
    (2.1)
    2.9
    (2.1)
    7. Secondary Outcome
    Title Duration of Analgesic Block
    Description Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration.
    Time Frame 24, 48, 72, 96 (if needed) hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Median (Inter-Quartile Range) [Hours]
    26
    27
    8. Secondary Outcome
    Title Sensory Resolution
    Description Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
    Time Frame 24, 48, 72, 96 (if needed) hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Median (Inter-Quartile Range) [Hours]
    27
    31
    9. Secondary Outcome
    Title Motor Block Resolution
    Description Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
    Time Frame 24, 48, 72, 96 (if needed) hours postoperatively

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Median (Inter-Quartile Range) [Hours]
    27
    27
    10. Secondary Outcome
    Title Time to Readiness for Discharge
    Description Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.
    Time Frame Postanesthesia care unit (0-6 hours postoperative)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Median (Inter-Quartile Range) [minutes]
    90
    90
    11. Secondary Outcome
    Title Postanesthesia Care Unit Length of Stay
    Description Total length of PACU stay as defined by time of PACU admission to PACU discharge.
    Time Frame Postanesthesia care unit (0-6 hours postoperative)

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    Measure Participants 55 56
    Median (Inter-Quartile Range) [minutes]
    163.5
    163

    Adverse Events

    Time Frame Up to 14 days following surgery
    Adverse Event Reporting Description At Risk patients for the Liposomal Bupivacaine group were 55 in count. However, due to lost to follow up, 43 of the 55 patients were analyzed for POD7-POD 14. At Risk patients for the Dexamethasone ISB group were 56 in count. However, due to lost to follow up, only 42 patients were able to be analyzed for POD7-POD14.
    Arm/Group Title Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Arm/Group Description Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
    All Cause Mortality
    Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/55 (0%) 0/56 (0%)
    Serious Adverse Events
    Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/55 (0%) 0/56 (0%)
    Other (Not Including Serious) Adverse Events
    Liposomal Bupivacaine & Standard Bupivacaine Standard Bupivacaine & Dexamethasone
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 6/55 (10.9%) 3/56 (5.4%)
    Nervous system disorders
    Postoperative neurologic symptoms at 7 days after surgery 6/43 (14%) 3/42 (7.1%)
    Postoperative neurologic symptoms at 14 days after surgery 0/43 (0%) 0/42 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE 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/Title Dr. David H. Kim
    Organization Hospital for Special Surgery
    Phone 212-606-1036
    Email kimd@hss.edu
    Responsible Party:
    Hospital for Special Surgery, New York
    ClinicalTrials.gov Identifier:
    NCT04047446
    Other Study ID Numbers:
    • 2019-0424
    First Posted:
    Aug 6, 2019
    Last Update Posted:
    Aug 1, 2022
    Last Verified:
    Jul 1, 2022