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

NCT03551847 | Withdrawn

• 1 other identifier: 16071701
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Outcome Measures

Primary Outcomes (2)

• 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.

  pre-operative to intraoperative

• 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.

  pre-operative to intraoperative

Secondary Outcomes (1)

• A change in culture results with antibiotic treatment

  pre-operative to intraoperative

Study Arms (2)

Oral antibiotic therapy group

EXPERIMENTAL

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

Drug: Antibiotic

No antibiotic therapy group

ACTIVE COMPARATOR

This group will not receive preoperative oral antibiotic therapy.

Drug: No antibiotics

Interventions

Antibiotic DRUG

The intervention involves giving an infected patient antibiotics.

Oral antibiotic therapy group

No antibiotics DRUG

The intervention involves not giving an infected patient antibiotics.

No antibiotic therapy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Infections

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Craig Della Valle, MD

  Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: June 11, 2018
• Study Start: July 1, 2011
• Primary Completion: November 5, 2019
• Study Completion: November 5, 2019
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)