NCT03790306

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

Completed Results posted Last updated 10 November 2020

What this trial tests

trial in Arthropathy of Hip Joint in 207 participants. Completed in 30 March 2020.

Timeline

15 January 2019

Primary endpoint
24 January 2020

30 March 2020

Quick facts

Lead sponsor	St. Elizabeth Medical Center, Utica, NY
Status	Completed
Study type	OBSERVATIONAL
Enrollment	207
Start date	15 January 2019
Primary completion	24 January 2020
Estimated completion	30 March 2020
Sites	1 location across United States

Conditions studied

• Arthropathy of Hip Joint — all drugs for Arthropathy of Hip Joint →
• Osteoarthritis, Hip — all drugs for Osteoarthritis, Hip →

Sponsor

St. Elizabeth Medical Center, Utica, NY

Who can join

Adults 30 to 100, any sex, with Arthropathy of Hip Joint or Osteoarthritis, Hip. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pre-operative Narcotic Use Primary · Pre-operatively

Percentage of patients that used used opioids pre-operatively

Group	Value	95% CI
THR With HANA Table	30

Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period Primary · 6 weeks

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

Group	Value	95% CI
THR With HANA Table	128

Short Physical Performance Battery Primary · 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.

Balance

Group	Value	95% CI
THR With HANA Table	3.95	± 0.31

Gait

Group	Value	95% CI
THR With HANA Table	3.89	± 0.45

Chair

Group	Value	95% CI
THR With HANA Table	3.17	± 1.31

Numeric Pain Scores Secondary · 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.

Best pain level

Group	Value	95% CI
THR With HANA Table	0.00966	± 0.139

Worst pain level

Group	Value	95% CI
THR With HANA Table	2.14	± 1.77

Sleep Quality Secondary · 6 Weeks

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

Group	Value	95% CI
THR With HANA Table	184

Number of Participants Who Adhere to Prescribed Post op Recovery Protocol Secondary · 2 weeks

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

Group	Value	95% CI
THR With HANA Table	206

Length of Stay in Hospital Secondary · 1 week

Average number of days in hospital after surgery

Group	Value	95% CI
THR With HANA Table	0.4175	0 – 6

Number of Patients That Return to Work 6 Weeks After Surgery Secondary · 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.

Group	Value	95% CI
THR With HANA Table	56

Number of Patients Who Return to Driving 6 Weeks After Surgery Secondary · 6 Weeks

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

Group	Value	95% CI
THR With HANA Table	182

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.