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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01712880

Enrollment

Registered

2012-10-24

Start date

2012-10-31

Completion date

2013-11-30

Last updated

2013-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periprosthetic Infection Total Hip Arthoplasty

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.

Interventions

PROCEDUREopen debridement with modular exchange

PROCEDUREone stage exchange

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026