InfectionNCT03503019
Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study
An observational study of Infection, run by Rothman Institute Orthopaedics.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision).
Who may be able to join
- all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision)
Who cannot join
- None
About this study
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
- 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.
- Conditions
- Infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diabetic | Not described | |
| Non-diabetic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Joint Infection
Measured: within 90 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503019
- Sponsor's protocol ID
- 18JPAR
- Status last verified
- Apr 2018
- First submitted
- 11 Apr 2018
- Last updated
- 19 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fructosamine as a Predictor of Surgical Outcomes in Total Joint Arthroplasty A Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT03503019
- Acronym / sponsor ID
- 18JPAR
- Conditions
- Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 19 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetic | – | – |
| Non-diabetic | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision).
Key inclusion criteria (1 listed)
- all patients undergoing elective total hip (THA) or knee (TKA) arthroplasty (primary and revision)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prosthetic Joint Infection
Time frame: within 90 days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, run by Rothman Institute Orthopaedics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Joint Infection (time frame: within 90 days of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.