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

Rothman Institute Orthopaedics logo

Rothman Institute Orthopaedics

Status

Unknown

Conditions

Infection

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

3,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None

Trial design

3,000 participants in 2 patient groups

Diabetic
Non-diabetic

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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