Trial Outcomes & Findings for Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty (NCT NCT03790306)

NCT ID: NCT03790306

Last Updated: 2020-11-10

Results Overview

Percentage of patients that used used opioids pre-operatively

• Recruitment status: COMPLETED
• Target enrollment: 207 participants
• Primary outcome timeframe: Pre-operatively
• Results posted on: 2020-11-10

Participant Flow

Participant milestones

Measure	THR With HANA Table Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Overall Study STARTED	207
Overall Study COMPLETED	207
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Age, Continuous	68.7 years STANDARD_DEVIATION 9.75 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants
Sex: Female, Male Male	91 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	202 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	207 participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-operatively

Percentage of patients that used used opioids pre-operatively

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Pre-operative Narcotic Use	30 Participants

PRIMARY outcome

Timeframe: 6 weeks

Number of patients that took any opioids throughout 6-week follow-up period

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period	128 Participants

PRIMARY outcome

Timeframe: 6 Weeks

Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Short Physical Performance Battery Balance	3.95 score on a scale Standard Deviation 0.31
Short Physical Performance Battery Gait	3.89 score on a scale Standard Deviation 0.45
Short Physical Performance Battery Chair	3.17 score on a scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: 6 Weeks

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.

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Numeric Pain Scores Best pain level	0.00966 units on a scale Standard Deviation 0.139
Numeric Pain Scores Worst pain level	2.14 units on a scale Standard Deviation 1.77

SECONDARY outcome

Timeframe: 6 Weeks

The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Sleep Quality	184 Participants

SECONDARY outcome

Timeframe: 2 weeks

Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Number of Participants Who Adhere to Prescribed Post op Recovery Protocol	206 Participants

SECONDARY outcome

Timeframe: 1 week

Average number of days in hospital after surgery

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Length of Stay in Hospital	0.4175 days Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: 6 weeks

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.

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Number of Patients That Return to Work 6 Weeks After Surgery	56 Participants

SECONDARY outcome

Timeframe: 6 Weeks

Patients will respond yes or no when asked if they have resumed driving.

Outcome measures

Measure	THR With HANA Table n=207 Participants Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Number of Patients Who Return to Driving 6 Weeks After Surgery	182 Participants

Adverse Events

THR With HANA Table

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Wickline, MD

Genesee Orthopedic & Hand Surgery Associates, P.C.

Phone: 315-735-4496

Email: awickline23@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place