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Opioid-free Accelerated Recovery Total Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03647709
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : October 3, 2018
Sponsor:
Collaborator:
Halyard Health
Information provided by (Responsible Party):
Dr Andrew B. Wickline, St. Elizabeth Medical Center, Utica, NY

Brief Summary:
To prove that total knee arthroplasty can be performed with little, if any need for opioids by using a combination of patient education, optimized pre-op and post-op pain and recovery protocols. The goal being opioid-free total knee arthroplasty.

Condition or disease Intervention/treatment
Arthropathy of Knee Joint Other: opioids

Detailed Description:

All study patients will receive a standardized protocol

  • All surgical procedures performed by single surgeon using same implants, approach, pre-op and post-op optimization, and simplified pain protocol at a single hospital or surgery center
  • Will attempt to minimize the number of anesthesiologists to further control variability in care

Methods:

  1. Pre-op Optimization

    • All patients enroll in education program
    • All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure
  2. Total Joint Procedure

    • Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block
  3. Data Collection

    • Electronic medical record chart review
    • Pre-op assessment and Post-op assessment (post anesthesia care unit (PACU), Phase II-prior to discharge
    • Phone calls after discharge
    • Follow-up assessment in surgeon's office
    • Swiftpath / KOOS JR surveys
  4. Pain Management Regimen

    • pre-op physical therapy teaching
    • post-op multimodal pain regimen

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opioid-Free Accelerated Recovery Total Knee Arthroplasty
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement


Intervention Details:
  • Other: opioids
    dosage frequency and duration


Primary Outcome Measures :
  1. Total knee replacement performed without opioids [ Time Frame: 12 months ]
    using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols

  2. Opiate Drugs [ Time Frame: 12 months ]
    Total quantity of opioids taken by patient after total knee arthroplasty


Secondary Outcome Measures :
  1. Site of Service Procedure Shift [ Time Frame: 90 days ]
    number of outpatient procedures versus inpatient procedures prior to new protocol/involved costs and overall savings to the institution post-protocol implementation

  2. cost of care by care type [ Time Frame: 90 days ]
    inpatient costs, analgesic use, physical therapy, physical therapy, anesthesia, pharmacy, home care, and post operative visits will be used to calculate the cumulative cost per 90 days

  3. comparison of change in patient's pain before surgery (baseline) versus after surgery pain when patient is at rest or with activity [ Time Frame: 6 weeks ]
    Pain level is measured by using a numeric pain rating scale from number 0 to number 10 ( where 0 represents no pain and 10 represents worst pain imaginable). This will be used to assess patient's level of pain relating to opioid use and recovery

  4. Knee Injury and Osteoarthritis Outcome Score short form (KOOS JR) [ Time Frame: 12 months ]
    This is a survey that is an assessment and questionnaire that rates a patients joint pain, stiffness and function in daily living. Patients answer questions about joint stiffness, pain and daily activities using the following scoring values: none=0, mild=1, moderate=2, severe=3, extreme=4 The values for all questions are added up to get a raw score that ranges from 0-28. This raw score is converted to an interval score using a provided table. The interval score ranges from 0-100 where 0 represents total knee disability and 100 represents perfect knee health.

  5. To prove nearly all patients can be treated as outpatient joint replacements using Swiftpath (an educational tool for patient undergoing total joint replacement) [ Time Frame: 12 months ]
    Swiftpath is a diary that patients follow from the initial booking of surgery through their recovery. It guides patients through potential risks involved with joint surgery, through a multimodal pain management protocol for pain prevention and through recovery.

  6. Protocol Adherence [ Time Frame: 3 weeks ]
    Exercise protocol for patients after total knee replacement. The patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.


Other Outcome Measures:
  1. Recidivism Rates [ Time Frame: 1 year ]
    recidivism rates are equal to or lower than top 200 orthopedic hospitals in the nation by following patient education and multimodal pain management protocol utilizing patient feedback and data obtained over a year from patient



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A Partial and total knee arthroplasty Unilateral only
Criteria

Inclusion Criteria:

  • Surgeries to be performed at hospital
  • Surgeries to be performed at surgery center
  • Ability to read and understand English
  • Primary care clearance for patients diagnosed with high blood pressure

Exclusion Criteria:

  • Disease states, patient conditions to exclude:

Schizophrenia Bipolar Disease Dementia

  • Known allergies to local anesthetics
  • Previous burn to affected extremity
  • BMI > 40
  • Nonoptimized anemia
  • Albumin less than 3.5
  • A1C > 8.0

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): NCT03647709


Contacts
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Contact: Mary Ann C Stevenson, Rph 315-735-4496 ext 2011 stevenson.maryann22@gmail.com
Contact: Andew B. Wickline, MD 315-735-4496 awickline23@gmail.com

Locations
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United States, New York
St Elizabeth Medical Center Recruiting
Utica, New York, United States, 13501
Contact: Andrew Wickline, MD    315-735-4496    awickline23@gmail.com   
Contact: Robert Cheron (IRB chairmain), MD    315-797-0254    rgcheron@gmail.com   
Sponsors and Collaborators
St. Elizabeth Medical Center, Utica, NY
Halyard Health
Investigators
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Principal Investigator: Andrew B Wickline, MD St Elizabeth Medical Center

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Responsible Party: Dr Andrew B. Wickline, Orthopedic Surgeon, St. Elizabeth Medical Center, Utica, NY
ClinicalTrials.gov Identifier: NCT03647709     History of Changes
Other Study ID Numbers: qllS
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents