Arthropathy of Hip JointNCT03790306
Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty
An observational study of Arthropathy of Hip Joint and Osteoarthritis, Hip, run by St. Elizabeth Medical Center, Utica, NY at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthropathy of Hip Joint, Osteoarthritis, Hip
- How many people
- 207 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 30 Mar 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Males and females presenting seeking elective unilateral total hip arthoplasty that fall within inclusion criteria listed above
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Elizabeth's Medical Center
Utica, New York, 13501
About this study
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.
Read the 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
- Conditions
- Arthropathy of Hip Joint, Osteoarthritis, Hip
- Medical subject headings
- Osteoarthritis, Hip
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-operative Narcotic Use
Percentage of patients that used used opioids pre-operatively
Measured: 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
Measured: 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.
Measured: 6 Weeks
Secondary outcomes (6)
Numeric Pain Scores
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.
Measured: 6 Weeks
Sleep Quality
The percentage of patients where pain interrupts sleep 'never' or 'rarely' will be combined together and reported.
Measured: 6 Weeks
Number of Participants Who Adhere to Prescribed Post op Recovery Protocol
Number of Participants Who Adhere to Prescribed Post op Recovery Protocol collected via a questionnaire
Measured: 2 weeks
Length of Stay in Hospital
Average number of days in hospital after surgery
Measured: 1 week
Number of Patients That Return to Work 6 Weeks After Surgery
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.
Measured: 6 weeks
Number of Patients Who Return to Driving 6 Weeks After Surgery
Patients will respond yes or no when asked if they have resumed driving.
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2018
- Study start15 Jan 2019
- Primary completion24 Jan 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthropathy of Hip JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Elizabeth Medical Center, Utica, NY
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Andrew B. Wickline, St. Elizabeth Medical Center, Utica, NY
- Investigators
- Andrew Wickline, MD, Principal investigator, St. Elizabeth's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790306
- Sponsor's protocol ID
- QIIIS
- Status last verified
- Oct 2020
- First submitted
- 20 Dec 2018
- Last updated
- 10 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid Free and Therapy Minimized Advantages Using HANA Table for Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT03790306
- Acronym / sponsor ID
- QIIIS
- Conditions
- Arthropathy of Hip Joint, Osteoarthritis, Hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- St. Elizabeth Medical Center, Utica, NYUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 24 Jan 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 31 Dec 2018 (actual)
- Results
- Posted 17 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females presenting seeking elective unilateral total hip arthoplasty that fall within inclusion criteria listed above
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patient diagnosis of schizophrenia, bipolar disease, dementia
- previous burn to affected extremity
- BMI > 40
- Hemoglobin <12 female, <13 male
- Albumin less than 3.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-operative Narcotic Use
Time frame: Pre-operatively
Percentage of patients that used used opioids pre-operatively
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
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.
6 secondary outcomes
Numeric Pain Scores
Time frame: 6 Weeks
Sleep Quality
Time frame: 6 Weeks
Number of Participants Who Adhere to Prescribed Post op Recovery Protocol
Time frame: 2 weeks
Length of Stay in Hospital
Time frame: 1 week
Number of Patients That Return to Work 6 Weeks After Surgery
Time frame: 6 weeks
Number of Patients Who Return to Driving 6 Weeks After Surgery
Time frame: 6 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Wickline, MD principal investigator
St. Elizabeth's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthropathy of Hip Joint and Osteoarthritis, Hip, run by St. Elizabeth Medical Center, Utica, NY at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-operative Narcotic Use (time frame: Pre-operatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.