NCT03503019

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. 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. 2.To compare the utility of fructosamine levels to HbA1c in predicting adverse outcomes.
  3. 3.To determine the "best" threshold of fructosamine to determine adverse outcomes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 19, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

April 19, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

April 11, 2018

Last Update Submit

April 11, 2018

Conditions

Infection

Outcome Measures

Primary Outcomes (1)

  • Prosthetic Joint Infection

    within 90 days of surgery

Study Arms (2)

Diabetic

Non-diabetic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2018

First Posted

April 19, 2018

Study Start

January 1, 2017

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

April 19, 2018

Record last verified: 2018-04