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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03790306
Other study ID # QIIIS
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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