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

NCT ID: NCT03503019

Last Updated: 2018-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2018-12-31

Brief 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.

Conditions

Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Diabetic

No interventions assigned to this group

Non-diabetic

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rothman Institute Orthopaedics

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

18JPAR

Identifier Type: -

Identifier Source: org_study_id