Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

Not Applicable

Withdrawn

• Conditions: Periprosthetic Infection Total Hip Arthoplasty
• Interventions: Procedure: open debridement with modular exchange; Procedure: one stage exchange

• Registration Number: NCT01712880
• Lead Sponsor: OrthoCarolina Research Institute, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-22
• Study First Submitted QC: 2012-10-22
• Study First Posted: 2012-10-24
• Status Verified: 2013-11
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open debridement with modular exchange	open debridement with modular exchange	-
one stage exchange	one stage exchange	-

Primary Outcome Measures

Name	Time	Method
Success	2 year	Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection

Trial Locations

Locations (1)

OrthoCarolina Research Institue; 🇺🇸 Charlotte, North Carolina, United States