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

NCT04622280 | Completed DMC

• 1 other identifier: 201105021RC
• Study Type: observational
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Prosthesis-Related Infections

Outcome Measures

Primary Outcomes (1)

• infection eradication

  without recurrent or persisted infection of the joint in one year

  2012-2019

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Documented prosthetic joint infection by pathology findings or cultures from either bone tissue, joint effusion, synovial fluid, or purulent discharge from aseptic operation technique
• Patient age ≧ 20 years old

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

NTUH

Taipei, Taiwan

Location

MeSH Terms

Conditions

Prosthesis-Related Infections

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• CHIN CHUAN JIANG, Professor

  NTUH

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University Hospital

Study Record Dates

• First Submitted: November 4, 2020
• First Posted: November 9, 2020
• Study Start: March 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 12, 2020

Record last verified: 2020-11

Locations

TW (1)