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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Periprosthetic Infection Total Hip Arthoplasty
- Sponsor
- OrthoCarolina Research Institute, Inc.
- Locations
- 1
- Primary Endpoint
- Success
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
- •Rising inflammatory seromarkers
- •Aspiration with a positive culture
Exclusion Criteria
- •Previous history of periprosthetic infection
- •Patients not willing to consent for the proposed treatment
- •Patients with altered mental status
- •Concurrent metastatic infection
- •Superficial Infection
Outcomes
Primary Outcomes
Success
Time Frame: 2 year
Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection