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Prospectively Observational Evaluation of Clinical Outcomes in Two-stage Revision for Periprosthetic Knee Infection

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ClinicalTrials.gov Identifier: NCT04622280
Recruitment Status : Completed
First Posted : November 9, 2020
Last Update Posted : November 12, 2020
Sponsor:
Information provided by (Responsible Party):
Statistical Center, NTUHCTC, National Taiwan University Hospital

Brief Summary:
Total knee arthroplasty (TKA) infection is a complication requiring multiple hospitalizations, operations, and outpatient visits placing a significant burden on both patient and treating surgeons. When revision surgery is needed, two kinds of treatment can be applied----one-stage and two-stage reimplantation procedure. The two-stage reimplantation procedure is considered the gold standard for treatment of subacute and chronic deep periprosthetic infections. Placement of antibiotic-loaded spacer is a standard procedure for eradication of peri-prosthetic joint infection. For better patient outcome, the purpose of this study was to determine the success rate of total knee infection patients treating with two-stage reimplantation procedure.

Condition or disease
Prosthesis-Related Infections

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Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospectively Observational Evaluation of Clinical Outcomes in Two-stage Reimplantation for Infected Knee Arthroplasty Patients
Actual Study Start Date : March 2011
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2019



Primary Outcome Measures :
  1. infection eradication [ Time Frame: 2012-2019 ]
    without recurrent or persisted infection of the joint in one year



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The investigators collected cases of infected TKAs treated with two-stage reimplantation procedure since 2011 in National Taiwan University Hospital.
Criteria

Inclusion criteria:

  1. Patients received primary total knee arthroplasty with acute prosthetic joint infection who were failed to antibiotics treatment or chronic prosthetic joint infection of knee AND
  2. Documented prosthetic joint infection by pathology findings or cultures from either bone tissue, joint effusion, synovial fluid, or purulent discharge from aseptic operation technique
  3. Patient age ≧ 20 years old

Exclusion criteria:

  1. Culture result shown Candida, mycobacterium or slow growing pathogens (e.g. nocardia)
  2. Patients with severe systemic diseases can not received second stage operation
  3. Pregnancy, terminal stage patients, inmates, aboriginal patients, student, mental disorder patients and other vulnerable patients will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04622280


Locations
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Taiwan
NTUH
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Study Chair: CHIN CHUAN JIANG, Professor NTUH
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Responsible Party: Statistical Center, NTUHCTC, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT04622280    
Other Study ID Numbers: 201105021RC
First Posted: November 9, 2020    Key Record Dates
Last Update Posted: November 12, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Infections
Prosthesis-Related Infections
Pathologic Processes
Postoperative Complications