Non-invasive Hemoglobin Monitoring in Outpatient Total NCT05369325

Updated 05/14/2024

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT05369325
Other study ID #	22-000012
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	June 15, 2022
Est. completion date	July 1, 2023

Study information
Verified date	July 2023
Source	Mayo Clinic
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status	Completed
Enrollment	200
Est. completion date	July 1, 2023
Est. primary completion date	July 1, 2023
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	All
Age group	18 Years and older
Eligibility	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 Design

Related Conditions & MeSH terms

Total Joint Arthroplasty

Locations
Country	Name	City	State
United States	Mayo Clinic Rochester	Rochester	Minnesota

Sponsors *(1)*
Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States,

Outcome
Type	Measure	Description	Time frame	Safety issue
Primary	Concordance between non-invasive Hgb and serum Hgb	How closely the non-invasive and serum Hgbs correlate with one another statistically	1 hour
Primary	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
Primary	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
Primary	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

See also
	Status	Clinical Trial	Phase
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	Active, not recruiting	`NCT03673293` - Measuring Postoperative Mobility, Gait Symmetry and Feedback Following TJA
	Active, not recruiting	`NCT01636414` - Reinfusion Drains vs Tranexamic Acid in Total Joint Arthroplasty	Phase 4
	Enrolling by invitation	`NCT05159739` - Genetic Susceptibility to Periprosthetic Joint Infections
	Completed	`NCT05286515` - A Pilot Study to Test the Feasibility of a Hybrid Preoperative Physical Therapy Intervention for Patients Undergoing Total Joint Arthroplasty	N/A
	Recruiting	`NCT04294693` - Total Joint Arthroplasty in a Pediatric Population
	Not yet recruiting	`NCT05858086` - Is Physical Therapy Clearance Before Arthroplasty Home Discharge Necessary?	N/A
	Enrolling by invitation	`NCT04590742` - Randomized Trial Investigating Melatonin Supplementation vs Placebo on Sleep Disturbance Following Total Joint Arthroplasty	N/A
	Enrolling by invitation	`NCT04592302` - The Impact of Smoking on Outcomes and Complications in Total Joint Arthroplasty: A Prospective Crossover Study
	Enrolling by invitation	`NCT04574752` - MSSA and MRSA Screening in Patients Undergoing Elective TJA: the Benefits of Next-generation Sequencing
	Completed	`NCT05399186` - Arthroplasty and Modifiable Risk Factors	N/A
	Completed	`NCT01577823` - Utility of Indwelling Catheter in Orthopaedic Patients Receiving Spinal Anesthesia	N/A

External Links

Mayo Clinic Clinical Trials