Opioid-free Accelerated Recovery Total Knee Arthroplasty

NCT03647709 | Completed Results DMC

• 1 other identifier: qllS
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy of Knee Joint

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Total Knee Replacement Performed Without Opioids Through 12 Weeks Postoperative

  Using a combination of patient education, optimized pre-operative and post-operative pain protocols and optimized recovery protocols

  12 weeks

• Number of Patients With Total Knee Arthroplasty Performed With Opiate Drugs Through 12 Weeks Postoperative

  The total number of opioid tablets taken by patient after total knee arthroplasty performed through 12 weeks postoperative

  12 weeks

Secondary Outcomes (7)

• Comparison of Change in Patient's Pain After Surgery At Various Time Intervals When Patient is at Rest and With Activity

  postoperative days 1,2,3,postoperative day 10-14, 3 weeks post surgery, 6 weeks post surgery and 12 weeks post surgery

• Knee Injury and Osteoarthritis Outcome Score Short Form (KOOS JR)

  Baseline (preoperative); 6 weeks post surgery; 12 weeks post surgery

• Number of Participants Using Swift Path Educational Tool as Outpatients for Total Joint Replacement

  6 weeks

• Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Days 10-14

  Postop Days10-14

• Number of Patients That Adhered to Exercise Protocol After Having Total Knee Arthroplasty - Postop Week 3

  postoperative 3 weeks

Interventions

opioids OTHER

dosage frequency and duration

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A Partial and total knee arthroplasty Unilateral only

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Elizabeth Medical Center, Utica, NY: lead
• Halyard Health: collaborator

Study Sites (1)

St Elizabeth Medical Center

Utica, New York, 13501, United States

Location

MeSH Terms

Interventions

Analgesics, Opioid

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Results Point of Contact

• Title: Dr Andrew Wickline
• Organization: St Elizabeth Medical Center

awickline23@gmail.com

315-735-4496

Study Officials

• Andrew B Wickline, MD

  St Elizabeth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: August 9, 2018
• First Posted: August 27, 2018
• Study Start: October 1, 2018
• Primary Completion: October 30, 2019
• Study Completion: April 30, 2020
• Last Updated: May 12, 2020
• Results First Posted: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)