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Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

NCT ID: NCT01712880

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-11-30

Brief Summary

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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

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Conditions

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Periprosthetic Infection Total Hip Arthoplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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open debridement with modular exchange

Group Type ACTIVE_COMPARATOR

open debridement with modular exchange

Intervention Type PROCEDURE

one stage exchange

Group Type ACTIVE_COMPARATOR

one stage exchange

Intervention Type PROCEDURE

Interventions

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open debridement with modular exchange

Intervention Type PROCEDURE

one stage exchange

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Midwest Orthopaedics at Rush

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role collaborator

OrthoCarolina Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OrthoCarolina Research Institue

Charlotte, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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12055

Identifier Type: -

Identifier Source: org_study_id