Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty
1 other identifier
observational
207
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2018
CompletedFirst Posted
Study publicly available on registry
December 31, 2018
CompletedStudy Start
First participant enrolled
January 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 24, 2020
CompletedResults Posted
Study results publicly available
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2020
CompletedNovember 10, 2020
October 1, 2020
1 year
December 20, 2018
February 5, 2020
October 21, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (6)
Numeric Pain Scores
6 Weeks
Sleep Quality
6 Weeks
Number of Participants Who Adhere to Prescribed Post op Recovery Protocol
2 weeks
Length of Stay in Hospital
1 week
Number of Patients That Return to Work 6 Weeks After Surgery
6 weeks
- +1 more secondary outcomes
Eligibility Criteria
Males and females presenting seeking elective unilateral total hip arthoplasty that fall within inclusion criteria listed above
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Elizabeth's Medical Center
Utica, New York, 13501, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Andrew Wickline, MD
- Organization
- Genesee Orthopedic & Hand Surgery Associates, P.C.
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Wickline, MD
St. Elizabeth's Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
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
December 20, 2018
First Posted
December 31, 2018
Study Start
January 15, 2019
Primary Completion
January 24, 2020
Study Completion
March 30, 2020
Last Updated
November 10, 2020
Results First Posted
March 17, 2020
Record last verified: 2020-10