Non-invasive Hemoglobin Monitoring in Outpatient Total Joint Arthroplasty

July 26, 2023 updated by: Matthew P. Abdel, M.D., Mayo Clinic

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing total joint arthroplasty at Mayo Clinic

Description

Inclusion Criteria:

  • Adult patients age ≥ 18.
  • Undergoing either primary total knee or total hip arthroplasty for a primary underlying diagnosis of osteoarthritis.

Exclusion Criteria:

- Individuals < 18 years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 hour
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
1 day
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
1 day
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Matthew Abdel, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

May 3, 2022

First Submitted That Met QC Criteria

May 5, 2022

First Posted (Actual)

May 11, 2022

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 26, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 22-000012

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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