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Completed

NCT Number: NCT03790306

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

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.

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Key information

Conditions

Arthropathy of Hip Joint Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Hip Rheumatic Diseases

Age range

30 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Elizabeth's Medical Center

Utica, New York, 13501, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pre-operative Narcotic Use

    Time frame: 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

    Time frame: 6 weeks

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

  3. Short Physical Performance Battery

    Time frame: 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 outcomes

  1. Numeric Pain Scores

    Time frame: 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

    Time frame: 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

    Time frame: 2 weeks

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

  4. Length of Stay in Hospital

    Time frame: 1 week

    Average number of days in hospital after surgery

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

    Time frame: 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

    Time frame: 6 Weeks

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

Sponsors and collaborators

Lead sponsor

St. Elizabeth Medical Center, Utica, NY

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 31, 2018
Registry last updated
Nov 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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