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OpenTrials
Completed

NCT Number: NCT03647709

Opioid-free Accelerated Recovery Total Knee Arthroplasty

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.

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Key information

Conditions

Arthropathy of Knee Joint

Sex eligibility

All sexes

Study type

Observational

Primary location

St Elizabeth Medical Center

Utica, New York, 13501, United States

About this study

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:

  • Pre-op Optimization
  • All patients enroll in education program
  • All patients have optimized BMI, hemoglobin, albumin, glucose control-A1C, and blood pressure
  • Total Joint Procedure
  • Tourniquet-free cemented total knee arthroplasty is performed with intra-articular block
  • 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
  • Pain Management Regimen
  • pre-op physical therapy teaching
  • post-op multimodal pain regimen

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

opioids

Other

dosage frequency and duration

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

St. Elizabeth Medical Center, Utica, NY

Other

Collaborators

  • Halyard Health

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Aug 27, 2018
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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