Total Joint ArthroplastyNCT05369325
Non-invasive Hemoglobin Monitoring in Outpatient Total Joint Arthroplasty
An observational study of Total Joint Arthroplasty, run by Mayo Clinic at 1 site in United States.
Trial summary
This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Joint Arthroplasty
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2022to 1 Jul 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing total joint arthroplasty at Mayo Clinic
Who may be able to join
- Adult patients age ≥ 18.
- Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.
Who cannot join
- Individuals < 18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty
This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty.
- Conditions
- Total Joint Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance between non-invasive Hgb and serum Hgb
How closely the non-invasive and serum Hgbs correlate with one another statistically
Measured: 1 hour
Patient satisfaction with non-invasive Hgb
Patients will get a survey to fill out following the Hgb measurements that assesses their satisfaction with the non-invasive method
Measured: 1 day
Nurse satisfaction with non-invasive Hgb
Nurses will get a survey to fill out following the Hgb measurements that assesses their satisfaction with the non-invasive method
Measured: 1 day
Cost comparison between non-invasive and serum Hgb
We will analyze cost differences between the non-invasive Hgb devices and the serum lab tests
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start15 Jun 2022
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Joint ArthroplastyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew P. Abdel, M.D., Mayo Clinic
- Investigators
- Matthew Abdel, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369325
- Sponsor's protocol ID
- 22-000012
- Status last verified
- Jul 2023
- First submitted
- 3 May 2022
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Non-invasive Hemoglobin Monitoring in Patients Undergoing Outpatient Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT05369325
- Acronym / sponsor ID
- 22-000012
- Conditions
- Total Joint Arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 15 Jun 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 11 May 2022 (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.
This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing total joint arthroplasty at Mayo Clinic
Key inclusion criteria (2 listed)
- Adult patients age ≥ 18.
- Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.
Key exclusion criteria (1 listed)
- Individuals < 18 years of age.
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
Concordance between non-invasive Hgb and serum Hgb
Time frame: 1 hour
How closely the non-invasive and serum Hgbs correlate with one another statistically
Patient satisfaction with non-invasive Hgb
Time frame: 1 day
Patients will get a survey to fill out following the Hgb measurements that assesses their satisfaction with the non-invasive method
Nurse satisfaction with non-invasive Hgb
Time frame: 1 day
Nurses will get a survey to fill out following the Hgb measurements that assesses their satisfaction with the non-invasive method
Cost comparison between non-invasive and serum Hgb
Time frame: 1 year
We will analyze cost differences between the non-invasive Hgb devices and the serum lab tests
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 27 Jul 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Matthew Abdel, MD principal investigator
Mayo Clinic
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 Total Joint Arthroplasty, run by Mayo Clinic 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 2 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 27 Jul 2023. 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?
Concordance between non-invasive Hgb and serum Hgb (time frame: 1 hour). The study lists 4 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 27 Jul 2023.