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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790306
• Other study ID #: QIIIS
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: March 30, 2020

Study information

• Verified date: October 2020
• Source: St. Elizabeth Medical Center, Utica, NY
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: March 30, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthropathy of Hip Joint
• Joint Diseases
• Osteoarthritis, Hip

Locations

Country	Name	City	State
United States	St. Elizabeth's Medical Center	Utica	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Elizabeth Medical Center, Utica, NY

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-operative Narcotic Use	Percentage of patients that used used opioids pre-operatively	Pre-operatively
Primary	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
Primary	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	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
Secondary	Sleep Quality	The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.	6 Weeks
Secondary	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
Secondary	Length of Stay in Hospital	Average number of days in hospital after surgery	1 week
Secondary	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
Secondary	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