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Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Midwest Orthopaedics at Rush
University of California, San Francisco
Emory University
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier:
NCT01712880
First received: October 22, 2012
Last updated: NA
Last verified: October 2012
History: No changes posted
  Purpose

The purpose of this study is to determine the success rate of two treatments for infection after total hip replacement: single stage arthroplasty exchange (your surgeon will take out your original implants and replace them with a complete new set) compared to irrigation and debridement with modular exchange (your surgeon will clean your implants with a surgical solution and take out the plastic liner and replace it with a new one - the rest of your hip implants will stay in place). The goal is to see if one is better than the other for the treatment of hip infection after a total hip replacement. A successful treatment means that you did not have to have another surgery on your hip for an infection-related reason.


Condition Intervention
Periprosthetic Infection Total Hip Arthoplasty
 Procedure: open debridement with modular exchange
Procedure: one stage exchange

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of the Acute Periprosthetic Hip Infection After Uncemented Total Hip Arthroplasty: A Randomized Study Comparing Open Debridement Component Retention (ODCR) With Modular Exchange Versus One Stage Exchange Arthroplasty

Further study details as provided by OrthoCarolina Research Institute, Inc.:

Primary Outcome Measures:
  • Success [ Time Frame: 2 year ] [ Designated as safety issue: Yes ]
    Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection


Estimated Enrollment: 60
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: open debridement with modular exchange Procedure: open debridement with modular exchange
Active Comparator: one stage exchange Procedure: one stage exchange

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Return to the OR for a drainage procedure within six weeks of index primary uncemented arthroplasty 1a) Exam findings within six weeks of index operation:

    • Drainage for more than 7 days
    • Wound appearance consistent with deep infection or hematoma
    • Persistent fever or evidence of bacteremia
    • All patients currently deemed appropriate for irrigation and debridement

  2. Labs

    - Rising inflammatory seromarkers

  3. Aspiration with a positive culture

Exclusion Criteria:

  1. Previous history of periprosthetic infection
  2. Prisoners
  3. Patients not willing to consent for the proposed treatment
  4. Patients with altered mental status
  5. Concurrent metastatic infection
  6. Superficial Infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712880

Locations
United States, North Carolina
OrthoCarolina Research Institue
Charlotte, North Carolina, United States, 28207
Sponsors and Collaborators
OrthoCarolina Research Institute, Inc.
Midwest Orthopaedics at Rush
University of California, San Francisco
Emory University
  More Information

No publications provided

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01712880     History of Changes
Other Study ID Numbers: 12055
Study First Received: October 22, 2012
Last Updated: October 22, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013