NCT03790306

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

January 15, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
2 months until next milestone

Results Posted

Study results publicly available

March 17, 2020

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

November 10, 2020

Status Verified

October 1, 2020

Enrollment Period

1 year

First QC Date

December 20, 2018

Results QC Date

February 5, 2020

Last Update Submit

October 21, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pre-operative Narcotic Use

    Percentage of patients that used used opioids pre-operatively

    Pre-operatively

  • 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

  • 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 Outcomes (6)

  • Numeric Pain Scores

    6 Weeks

  • Sleep Quality

    6 Weeks

  • Number of Participants Who Adhere to Prescribed Post op Recovery Protocol

    2 weeks

  • Length of Stay in Hospital

    1 week

  • Number of Patients That Return to Work 6 Weeks After Surgery

    6 weeks

  • +1 more secondary outcomes

Eligibility Criteria

Age30 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Males and females presenting seeking elective unilateral total hip arthoplasty that fall within inclusion criteria listed above

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Elizabeth's Medical Center

Utica, New York, 13501, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Results Point of Contact

Title
Andrew Wickline, MD
Organization
Genesee Orthopedic & Hand Surgery Associates, P.C.

Study Officials

  • Andrew Wickline, MD

    St. Elizabeth's Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Surgeon

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 31, 2018

Study Start

January 15, 2019

Primary Completion

January 24, 2020

Study Completion

March 30, 2020

Last Updated

November 10, 2020

Results First Posted

March 17, 2020

Record last verified: 2020-10

Locations