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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03503019

Enrollment

3000

Registered

2018-04-19

Start date

2017-01-01

Completion date

2018-12-31

Last updated

2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame
Prosthetic Joint Infection	within 90 days of surgery

Outcome results