Knee OsteoarthritisNCT03071250
An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty
An observational study of Knee Osteoarthritis and Hip Osteoarthritis, run by University of Arkansas at 1 site in United States.
Trial summary
The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Hip Osteoarthritis, Knee Arthritis
- What is being tested?
- Total knee or Hip Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects must meet all of the inclusion and exclusion criteria to be enrolled in the study. All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.
Who may be able to join
- All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for MEdical Sciences
Little Rock, Arkansas, 72205
About this study
The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery, anesthetic care focused on postoperative nausea and vomiting prevention and optimizing immediate postoperative functional ability, and aggressive postoperative physical therapy.
This is an observational study to look at the outcomes of this program at University of Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and vomiting, and 30-day readmission rates, and health literacy rates.
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis, Knee Arthritis, Hip Arthritis
- Being tested
- Total knee or Hip Arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee or Hip ArthroplastyProcedure or surgery
Patients who received either a total knee or hip arthroplasty will be identified
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay
Postoperative hospital length of stay
Measured: 7/1/2015 - 7/1/2016
Secondary outcomes (5)
narcotic consumption
30-day postoperative narcotic consumption
Measured: 7/1/2015 - 7/1/2016
Pain scores
postoperative VAS pain scores
Measured: 7/1/2015 - 7/1/2016
30-day readmission
30-day hospital readmission following procedure
Measured: 7/1/2015 - 7/1/2016
infection
Surgical site infections
Measured: 7/1/2015 - 7/1/2016
PONV
postoperative nausea and vomiting
Measured: 7/1/2015 - 7/1/2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start1 Oct 2018
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03071250
- Sponsor's protocol ID
- 206501
- Status last verified
- Jul 2019
- First submitted
- 1 Mar 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03071250
- Acronym / sponsor ID
- 206501
- Conditions
- Knee Osteoarthritis, Hip Osteoarthritis, Knee Arthritis, Hip Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery, anesthetic care focused on postoperative nausea and vomiting prevention and optimizing immediate postoperative functional ability, and aggressive postoperative physical therapy.
This is an observational study to look at the outcomes of this program at University of Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and vomiting, and 30-day readmission rates, and health literacy rates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects must meet all of the inclusion and exclusion criteria to be enrolled in the study. All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.
Key inclusion criteria (1 listed)
- All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee or Hip ArthroplastyPatients who received either a total knee or hip arthroplasty will be identified | Procedure or surgery | – |
Primary outcome
Length of Stay
Time frame: 7/1/2015 - 7/1/2016
Postoperative hospital length of stay
5 secondary outcomes
narcotic consumption
Time frame: 7/1/2015 - 7/1/2016
Pain scores
Time frame: 7/1/2015 - 7/1/2016
30-day readmission
Time frame: 7/1/2015 - 7/1/2016
infection
Time frame: 7/1/2015 - 7/1/2016
PONV
Time frame: 7/1/2015 - 7/1/2016
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Knee Osteoarthritis and Hip Osteoarthritis, run by University of Arkansas 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 1 inclusion and 1 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 24 Jul 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of Stay (time frame: 7/1/2015 - 7/1/2016). 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 24 Jul 2019.