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The Effect of Oral Antibiotics on Synovial Fluid and Differential for the Diagnosis of Infection

Primary Purpose

Infection

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Antibiotic
No antibiotics
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient>18 years old.
  2. Patient with a prosthetic hip or knee in place.
  3. Patient with PJI of the hip or knee based on MSIS criteria3(Table 1).
  4. Patient off of antibiotics for a minimum of two weeks prior to preoperative joint aspiration.
  5. Patient with a culture-positive preoperative joint aspiration

Exclusion Criteria:

  1. Inadequate preoperative or intraoperative synovial fluid sample to perform synovial fluid WBC, %PMN and aerobic/anaerobic cultures.
  2. Pregnant women.

Sites / Locations

  • Rush University medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Oral antibiotic therapy group

No antibiotic therapy group

Arm Description

This group will receive preoperative oral antibiotic therapy tailored to the infecting organism (if identified) for two weeks before the time of revision surgery

This group will not receive preoperative oral antibiotic therapy.

Outcomes

Primary Outcome Measures

A change in synovial fluid white blood cell count with antibiotic treatment
White blood cell count will be measured from synovial fluid. This fluid will be sent to our in-house laboratory testing facility. WBC is measured as the total number per mL of fluid.
A change in synovial fluid neutrophil percentage with antibiotic treatment
Neutrophil percentage will be measured from synovial fluid. This fluid will be sent to our in-house laboratory testing facility. %PMN is a percentage out of total white blood cell count.

Secondary Outcome Measures

A change in culture results with antibiotic treatment
Synovial fluid will be sent to our in-house lab and they will try and grow cultures from this fluid to see if they can identify the organism causing the infection.

Full Information

First Posted
October 26, 2017
Last Updated
August 16, 2021
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03551847
Brief Title
The Effect of Oral Antibiotics on Synovial Fluid and Differential for the Diagnosis of Infection
Official Title
The Effect of Oral Antibiotics on Synovial Fluid Leukocyte Count and Differential for the Diagnosis of Periprosthetic Hip and Knee Infection
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to enroll any subjects, closed study
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
November 5, 2019 (Actual)
Study Completion Date
November 5, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Periprosthetic joint infection following total hip or knee arthroplasty is a rare but potentially devastating complication. Accurate diagnosis of these infections remains one of the most challenging undertakings in orthopaedics. Multiple studies have shown the high diagnostic accuracy of synovial fluid white blood cell count (WBC) and neutrophil percentage (%PMNs) in detecting PJI. This study's goal is to evaluate how antibiotics affect those two important diagnostic measures.
Detailed Description
Periprosthetic joint infection (PJI) following total hip or knee arthroplasty is a rare but potentially devastating complication. Accurate diagnosis of these infections remains one of the most challenging undertakings in orthopaedics. Clinical presentation of PJI may be subtle and distinguishing between infection versus aseptic issues can be difficult. Currently no diagnostic approach has been developed that accurately and unequivocally diagnoses PJI. Multiple studies have shown the high diagnostic accuracy of synovial fluid white blood cell count (WBC) and neutrophil percentage (%PMNs) in detecting PJI. This has led to incorporation of these two parameters into criteria for the diagnosis of PJI. WBC and %PMN cutoffs have been published for prosthetic hips and knees in both the acute and chronic setting. Meanwhile, synovial fluid cell counts are believed to be of particular value when patients present on systemic antibiotics, which have been shown to compromise intraarticular cultures by causing false negative results. However, the effect of antibiotics on synovial fluid cell count and differential has not been well delineated. One prospective study by Trampuz et al. of 133 synovial fluid specimens prior to total knee revisions noted that patients receiving antimicrobial agents had lower leukocyte counts than did those who were not receiving antimicrobial agents. To the contrary, a recent animal study examined intra-articular administration of the antibiotic amikacin in horses and reported a statistically significant increase in the synovial nucleated cell count. The effect of antibiotics on synovial fluid WBC and %PMN thus remains unclear. Furthermore, to reduce false-negative culture results, it is recommended that patients be off of antibiotics for a minimum of two weeks prior to obtaining samples for culture. Investigators have shown reduced false-negative culture rates in patients not taking antibiotics prior to surgery compared to those taking antibiotics at the time of surgery. However, the two-week time interval is relatively arbitrary and adequate supporting data do not exist. The primary aim of this study is to evaluate how antibiotics affect synovial fluid leukocyte and differential counts. A secondary aim is to assess how long patients need to be off of antibiotic therapy to generate accurate synovial fluid cultures. Further examination of the effects of systemic antibiotics on synovial fluid composition will provide valuable information for clinicians caring for patients with possible PJI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral antibiotic therapy group
Arm Type
Experimental
Arm Description
This group will receive preoperative oral antibiotic therapy tailored to the infecting organism (if identified) for two weeks before the time of revision surgery
Arm Title
No antibiotic therapy group
Arm Type
Active Comparator
Arm Description
This group will not receive preoperative oral antibiotic therapy.
Intervention Type
Drug
Intervention Name(s)
Antibiotic
Intervention Description
The intervention involves giving an infected patient antibiotics.
Intervention Type
Drug
Intervention Name(s)
No antibiotics
Intervention Description
The intervention involves not giving an infected patient antibiotics.
Primary Outcome Measure Information:
Title
A change in synovial fluid white blood cell count with antibiotic treatment
Description
White blood cell count will be measured from synovial fluid. This fluid will be sent to our in-house laboratory testing facility. WBC is measured as the total number per mL of fluid.
Time Frame
pre-operative to intraoperative
Title
A change in synovial fluid neutrophil percentage with antibiotic treatment
Description
Neutrophil percentage will be measured from synovial fluid. This fluid will be sent to our in-house laboratory testing facility. %PMN is a percentage out of total white blood cell count.
Time Frame
pre-operative to intraoperative
Secondary Outcome Measure Information:
Title
A change in culture results with antibiotic treatment
Description
Synovial fluid will be sent to our in-house lab and they will try and grow cultures from this fluid to see if they can identify the organism causing the infection.
Time Frame
pre-operative to intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient>18 years old. Patient with a prosthetic hip or knee in place. Patient with PJI of the hip or knee based on MSIS criteria3(Table 1). Patient off of antibiotics for a minimum of two weeks prior to preoperative joint aspiration. Patient with a culture-positive preoperative joint aspiration Exclusion Criteria: Inadequate preoperative or intraoperative synovial fluid sample to perform synovial fluid WBC, %PMN and aerobic/anaerobic cultures. Pregnant women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Della Valle, MD
Organizational Affiliation
Professor of Orthopaedic Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Oral Antibiotics on Synovial Fluid and Differential for the Diagnosis of Infection

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