Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty

To prove that anterior approach total hip arthroplasty using the HANA table can be performed with little, if any, need for opioids using a combination of education, optimized pre op and post op pain protocols and optimized recovery tools.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Hip; Arthropathy of Hip Joint

Detailed Description

Methods:

Data Collection:

• pre-op assessment/physical therapy evaluation
• post op assessment - PACU, phase II (Prior to discharge)
• phone calls after discharge (post op day 1, 2, 3)
• follow up assessment in surgeon's office (3 and 6 weeks post op)
• Ortech
• Swiftpath
• HOOS jr

Pre-optimization:

• All patients enroll in SwiftPath education program
• Optimized BMI, hemoglobin, albumin, glucose control, A1C and blood pressure control

Total Joint procedure:

-anterior approach using the HANA table THA preformed with intra-articular block

Pain Management regimen:

• Pre op PT teaching
• post op multimodal pain regimen

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• United States
  • New York
    • Utica, New York, United States, 13501
      • St. Elizabeth's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Males and females presenting seeking elective unilateral total hip arthoplasty that fall within inclusion criteria listed above

Description

Inclusion Criteria:

• Elective total hip arthroplasty
• unilateral
• patient surgeries scheduled to be performed at the hospital and surgery center
• patients must enroll in SwiftPath
• Ability to read and understand English

Exclusion Criteria:

• Patient diagnosis of schizophrenia, bipolar disease, dementia
• previous burn to affected extremity
• BMI > 40
• Hemoglobin <12 female, <13 male
• Albumin less than 3.5
• A1C >8.0

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative Narcotic Use	Percentage of patients that used used opioids pre-operatively	Pre-operatively
Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period	Number of patients that took any opioids throughout 6-week follow-up period	6 weeks
Short Physical Performance Battery	Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.	6 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Pain Scores	A numeric pain score (0-10, 0 is no pain and 10 is worst imaginable pain). This will be used to assess patients level of pain relating to opioid use and recovery. Both 'best' pain level and 'worst' pain level as reported by the patient will be reported.	6 Weeks
Sleep Quality	The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.	6 Weeks
Number of Participants Who Adhere to Prescribed Post op Recovery Protocol	Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire	2 weeks
Length of Stay in Hospital	Average number of days in hospital after surgery	1 week
Number of Patients That Return to Work 6 Weeks After Surgery	questionnaire asking the patient to report whether or not they have returned to employment and at what capacity (using Department of Labor physical employment scale). Patients will answer "yes" or "no" when asked if they have returned to work.	6 weeks
Number of Patients Who Return to Driving 6 Weeks After Surgery	Patients will respond yes or no when asked if they have resumed driving.	6 Weeks

Collaborators and Investigators

• Sponsor: St. Elizabeth Medical Center, Utica, NY
• Investigators: Principal Investigator: Andrew Wickline, MD, St. Elizabeth's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2019
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): March 30, 2020

Study Registration Dates

• First Submitted: December 20, 2018
• First Submitted That Met QC Criteria: December 27, 2018
• First Posted (Actual): December 31, 2018

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: October 21, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: QIIIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No