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

• Sponsor: St. Elizabeth Medical Center, Utica, NY (Other)
• Overall Status: Completed
• CT.gov ID: NCT03790306
• Collaborator: (none)
• Enrollment: 207
• Location: 1
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 14.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Arthropathy of Hip Joint; Osteoarthritis, Hip

Detailed 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

Study Design

• Study Type: Observational
• Actual Enrollment: 207 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty
• Actual Study Start Date: Jan 15, 2019
• Actual Primary Completion Date: Jan 24, 2020
• Actual Study Completion Date: Mar 30, 2020

Outcome Measures

Primary Outcome Measures

1. Pre-operative Narcotic Use [Pre-operatively]

   Percentage of patients that used used opioids pre-operatively

2. Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period [6 weeks]

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

3. Short Physical Performance Battery [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.

Secondary Outcome Measures

1. Numeric Pain Scores [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.

2. Sleep Quality [6 Weeks]

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

3. Number of Participants Who Adhere to Prescribed Post op Recovery Protocol [2 weeks]

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

4. Length of Stay in Hospital [1 week]

   Average number of days in hospital after surgery

5. Number of Patients That Return to Work 6 Weeks After Surgery [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.

6. Number of Patients Who Return to Driving 6 Weeks After Surgery [6 Weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Elizabeth's Medical Center	Utica	New York	United States	13501

Sponsors and Collaborators

• St. Elizabeth Medical Center, Utica, NY

Investigators

• Principal Investigator: Andrew Wickline, MD, St. Elizabeth's Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 13, 2020

More Information

Publications

None provided.

• Responsible Party: Dr Andrew B. Wickline, Orthopedic Surgeon, St. Elizabeth Medical Center, Utica, NY
• ClinicalTrials.gov Identifier: NCT03790306
• Other Study ID Numbers: QIIIS
• First Posted: Dec 31, 2018
• Last Update Posted: Nov 10, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis, Hip

Study Results

Participant Flow

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Period Title: Overall Study
STARTED	207
COMPLETED	207
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Overall Participants	207
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.7 (9.75)
Sex: Female, Male (Count of Participants)
Female	116 56%
Male	91 44%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	5 2.4%
White	202 97.6%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	207 100%

Outcome Measures

1. Primary Outcome

Title	Pre-operative Narcotic Use
Description	Percentage of patients that used used opioids pre-operatively
Time Frame	Pre-operatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Count of Participants [Participants]	30 14.5%

2. Primary Outcome

Title	Number of Patients That Took Any Opioids Throughout 6-week Follow-up Period
Description	Number of patients that took any opioids throughout 6-week follow-up period
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Count of Participants [Participants]	128 61.8%

3. Primary Outcome

Title	Short Physical Performance Battery
Description	Assessment tool measuring gait speed, balance and chair stand test. Scores range from 0 to 4 with higher scores indicating a better outcome.
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Balance	3.95 (0.31)
Gait	3.89 (0.45)
Chair	3.17 (1.31)

4. Secondary Outcome

Title	Numeric Pain Scores
Description	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.
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Best pain level	0.00966 (0.139)
Worst pain level	2.14 (1.77)

5. Secondary Outcome

Title	Sleep Quality
Description	The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Count of Participants [Participants]	184 88.9%

6. Secondary Outcome

Title	Number of Participants Who Adhere to Prescribed Post op Recovery Protocol
Description	Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Count of Participants [Participants]	206 99.5%

7. Secondary Outcome

Title	Length of Stay in Hospital
Description	Average number of days in hospital after surgery
Time Frame	1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Mean (Full Range) [days]	0.4175

8. Secondary Outcome

Title	Number of Patients That Return to Work 6 Weeks After Surgery
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) using the Hip And kNee Arthroplasty (HANA) table
Measure Participants	207
Count of Participants [Participants]	56 27.1%

9. Secondary Outcome

Title	Number of Patients Who Return to Driving 6 Weeks After Surgery
Description	Patients will respond yes or no when asked if they have resumed driving.
Time Frame	6 Weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
Measure Participants	207
Count of Participants [Participants]	182 87.9%

Adverse Events

Time Frame	1 year
Arm/Group Title	THR With HANA Table
Arm/Group Description	Patients undergoing Total Hip Replacement (THR) with use of the Hip And kNee Arthroplasty (HANA) table.
All Cause Mortality
	THR With HANA Table
	Affected / at Risk (%)	# Events
Total	0/207 (0%)
Serious Adverse Events
	THR With HANA Table
	Affected / at Risk (%)	# Events
Total	0/207 (0%)
Other (Not Including Serious) Adverse Events
	THR With HANA Table
	Affected / at Risk (%)	# Events
Total	0/207 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.