Periprosthetic Infection Total Hip Arthoplasty Clinical Trial
Official title:
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2013 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | OrthoCarolina Research Institue | Charlotte | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| OrthoCarolina Research Institute, Inc. | Emory University, Midwest Orthopaedics at Rush, University of California, San Francisco |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success | Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection | 2 year | Yes |