Use of Antibiotic Carrier in Acute Periprosthetic Infections (APPI) of Total Knee Replacements

November 24, 2014 updated by: Michael Muldoon, M.D.

Use of Antibiotic Contained Calcium Sulfate Carrier in Acute Periprosthetic Infections(APPI) of Total Knee Replacements

The purpose of the study is to gather information on the use of Stimulan, the surgery, and anitbiotics to whetether the APPI has decreased or shown improvement when compared to study participants who did not receive Stimulan during their revision total knee replacement surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Southwest Orthopedic Group, LLP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Total knee replacement and have developed either APPI within 28 dyas of surgery, or an acute onset of a hematogenous (blood-source ) infection in knee, more than 30 days after surgery with symptoms present less than 28 days

Description

Inclusion Criteria:

  • APPI within 28 days of primary TKR
  • Acute hematogenous infection within 4 weeks of symptoms

Exclusion Criteria:

  • Exposed prosthesis
  • Infection occuring in revised joints
  • Poly articular infections
  • have allergies to tobramycin or Vancomycin
  • previous chronic infections in or around any ipsilateral extremity trauma or implants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
APPI of TKR-Stimulan
Surgery Stimulan beads 2.4 G Tobramycin 2.0 G Vancomycin
Procedure: APPI of TKR-Stimulan
Other Names:
  • Vancomycin
  • Tobramycin
  • Stimulan
APPI of TKR-historical
Surgery 2.4 G Tobramycin 2.0 G Vancomycin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retention of components
Time Frame: 12 months
12 months
Eradication of infection
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
C-Reactive protein (CRP)
Time Frame: 12 months
12 months
Wound complications
Time Frame: 12 months
12 months
Knee Society Score
Time Frame: 12 months
12 months
Visual Analog Scale
Time Frame: 12 months
12 months
Outcome Assessment Scores
Time Frame: 12 months
12 months
Ongoing use of antibiotics
Time Frame: 6 weeks
6 weeks
AP and lateral Radiographs of involved joint
Time Frame: 12 months
12 months
Positive synovial fluid cell count
Time Frame: pre-operative
pre-operative
Sedimentation Rate
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Muldoon, M.D.

Collaborators

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Michael P Muldoon, MD, Sharp HealthCare
  • Principal Investigator: David R Lionberger, MD, Southwest Orthopedic Group, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 4, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 8, 2014

Study Record Updates

Last Update Posted (Estimate)

November 26, 2014

Last Update Submitted That Met QC Criteria

November 24, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1112-0211

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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