Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Periprosthetic Infection Total Hip Arthoplasty
• Intervention / Treatment: Procedure: open debridement with modular exchange; Procedure: one stage exchange

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • OrthoCarolina Research Institue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: open debridement with modular exchange	Procedure: open debridement with modular exchange
Active Comparator: one stage exchange	Procedure: one stage exchange

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success	Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection	2 year

Collaborators and Investigators

• Sponsor: OrthoCarolina Research Institute, Inc.
• Collaborators: Emory University; University of California, San Francisco; Midwest Orthopaedics at Rush

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 22, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (Estimate): October 24, 2012

Study Record Updates

• Last Update Posted (Estimate): November 6, 2013
• Last Update Submitted That Met QC Criteria: November 5, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 12055