Clinical trial NCT03647709: Opioid-free Accelerated Recovery Total Knee Arthroplasty
Official title: Opioid-Free Accelerated Recovery Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Knee Joint
Lead sponsor: St. Elizabeth Medical Center, Utica, NY
Sponsor class: OTHER
Collaborators: name: Halyard Health
First posted: 2018-08-27
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A Partial and total knee arthroplasty Unilateral only

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.

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

Eligibility 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

Primary outcomes:
measure: Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative
timeFrame: 12 weeks
measure: Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative
timeFrame: 12 weeks
Secondary outcomes:
measure: Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity
timeFrame: postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery
measure: Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)
timeFrame: Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery
measure: Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement
timeFrame: 6 weeks
measure: Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14
timeFrame: Postop Days10-14
measure: Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3
timeFrame: postoperative 3 weeks
measure: Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 6
timeFrame: Postoperative 6 weeks
measure: Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Post Week 12
timeFrame: Postoperative 12 weeks
Other outcomes:
Locations:
city: Utica
country: United States
facility: St Elizabeth Medical Center
state: New York
Study officials:
affiliation: St Elizabeth Medical Center
name: Andrew B Wickline, MD
role: PRINCIPAL_INVESTIGATOR
References: