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NCT03503019 Clinical Trial

Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study

Infection Clinical Trial

Official title:
Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03503019
Other study ID # 18JPAR
Secondary ID
Status Enrolling by invitation
Phase
First received April 11, 2018
Last updated April 11, 2018
Start date January 1, 2017
Est. completion date December 31, 2018

Study information
Verified date April 2018
Source Rothman Institute Orthopaedics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A prospective multicenter study including all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision). Patients will be screened for glycemic control using HbA1c levels, fructosamine levels, and blood glucose levels. Blood samples will be obtained at the preadmission testing (PAT) within 30 days of surgery. On postoperative day 1 (POD-1), morning glucose levels will be obtained for all patients as well. Patients will be followed up for 90 days postop.

Study aims

1. To examine the association between serum fructosamine levels and the risk for adverse outcomes (mainly PJI) following TJA among patients with and without diabetes.

2. To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes.

3. To determine the "best" threshold of fructosamine to determine adverse outcomes.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 3000
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision)

Exclusion Criteria:

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Rothman Institute Orthopaedics

Outcome
Type Measure Description Time frame Safety issue
Primary Prosthetic Joint Infection within 90 days of surgery
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