Trials / Unknown
UnknownNCT03503019
Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,000 (estimated)
- Sponsor
- Rothman Institute Orthopaedics · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Timeline
- Start date
- 2017-01-01
- Primary completion
- 2018-12-31
- Completion
- 2018-12-31
- First posted
- 2018-04-19
- Last updated
- 2018-04-19
Source: ClinicalTrials.gov record NCT03503019. Inclusion in this directory is not an endorsement.