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Opioid-free Accelerated Recovery Total Knee Arthroplasty

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: NCT03647709
Recruitment Status : Completed
First Posted : August 27, 2018
Results First Posted : May 12, 2020
Last Update Posted : May 12, 2020
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
    • Swift path / KOOS JR surveys
  4. Pain Management Regimen

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

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Opioid-Free Accelerated Recovery Total Knee Arthroplasty
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : April 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. Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative [ Time Frame: 12 weeks ]
    Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols

  2. Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative [ Time Frame: 12 weeks ]
    The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative


Secondary Outcome Measures :
  1. Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity [ Time Frame: postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery ]
    Pain level is measured by the Numerical Rating Scale (NRS) for pain utilizing minimum number 0 to maximum number 10 (0 represents no pain and 10 represents worst pain imaginable). The higher the number reported the worst the pain/outcome. This will be used to assess patient's level of pain relating to opioid use and recovery.

  2. Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) [ Time Frame: Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery ]
    The Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR) 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: 0=none, 1=mild, 2=moderate, 3=severe, 4=extreme. The values for all questions are added up to get a raw score that ranges from a minimum of 0 to a maximum of 28. This raw score is converted to an interval score using a provided table. The interval score ranges from a minimum of 0 to a maximum of 100 where 0 = total knee disability and 100 = perfect knee health. The higher the score on scale from 0 to 100 the better the outcome.

  3. Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement [ Time Frame: 6 weeks ]
    Swift path is an Educational tool (diary) for patients undergoing total joint replacement, 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.

  4. Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14 [ Time Frame: Postop Days10-14 ]
    Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.

  5. Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3 [ Time Frame: postoperative 3 weeks ]
    Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.

  6. Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6 [ Time Frame: Postoperative 6 weeks ]
    Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.

  7. Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12 [ Time Frame: Postoperative 12 weeks ]
    Exercise protocol for patients after total knee replacement where the patient performs a series of exercises every hour to help prevent blood clots and achieve appropriate range of motion goals.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Locations
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United States, New York
St Elizabeth Medical Center
Utica, New York, United States, 13501
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
  Study Documents (Full-Text)

Documents provided by Dr Andrew B. Wickline, St. Elizabeth Medical Center, Utica, NY:
Study Protocol  [PDF] April 30, 2020
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Dr Andrew B. Wickline, Orthopedic Surgeon, St. Elizabeth Medical Center, Utica, NY
ClinicalTrials.gov Identifier: NCT03647709    
Other Study ID Numbers: qllS
First Posted: August 27, 2018    Key Record Dates
Results First Posted: May 12, 2020
Last Update Posted: May 12, 2020
Last Verified: May 2020
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