Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study
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|ClinicalTrials.gov Identifier: NCT03503019|
Recruitment Status : Unknown
Verified April 2018 by Rothman Institute Orthopaedics.
Recruitment status was: Enrolling by invitation
First Posted : April 19, 2018
Last Update Posted : April 19, 2018
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.
- To examine the association between serum fructosamine levels and the risk for adverse outcomes (mainly PJI) following TJA among patients with and without diabetes.
- To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes.
- To determine the "best" threshold of fructosamine to determine adverse outcomes.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- Prosthetic Joint Infection [ Time Frame: within 90 days of surgery ]