NCT05369325

Brief Summary

This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

1 year

First QC Date

May 3, 2022

Last Update Submit

July 26, 2023

Conditions

Total Joint Arthroplasty

Outcome Measures

Primary Outcomes (4)

  • Concordance between non-invasive Hgb and serum Hgb

    How closely the non-invasive and serum Hgbs correlate with one another statistically

    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

    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

    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

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing total joint arthroplasty at Mayo Clinic

You may qualify if:

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

You may not qualify if:

  • \- Individuals \< 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Study Officials

  • Matthew Abdel, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 11, 2022

Study Start

June 15, 2022

Primary Completion

July 1, 2023

Study Completion

July 1, 2023

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

US(1)