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Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

This study has been withdrawn prior to enrollment.
(The study was not feasible.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01712880
First Posted: October 24, 2012
Last Update Posted: November 6, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Midwest Orthopaedics at Rush
University of California, San Francisco
Emory University
Information provided by (Responsible Party):
OrthoCarolina Research Institute, Inc.
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection


Enrollment: 0
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: OrthoCarolina Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT01712880     History of Changes
Other Study ID Numbers: 12055
First Submitted: October 22, 2012
First Posted: October 24, 2012
Last Update Posted: November 6, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Infection
Communicable Diseases