Study Stopped
The study was not feasible.
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2012
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 22, 2012
CompletedFirst Posted
Study publicly available on registry
October 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 6, 2013
November 1, 2013
1.1 years
October 22, 2012
November 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Success
Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection
2 year
Study Arms (2)
open debridement with modular exchange
ACTIVE COMPARATORone stage exchange
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
- Labs
- \- Rising inflammatory seromarkers
- Aspiration with a positive culture
You may not qualify if:
- Previous history of periprosthetic infection
- Prisoners
- Patients not willing to consent for the proposed treatment
- Patients with altered mental status
- Concurrent metastatic infection
- Superficial Infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OrthoCarolina Research Institute, Inc.lead
- Midwest Orthopaedics at Rushcollaborator
- University of California, San Franciscocollaborator
- Emory Universitycollaborator
Study Sites (1)
OrthoCarolina Research Institue
Charlotte, North Carolina, 28207, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2012
First Posted
October 24, 2012
Study Start
October 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 6, 2013
Record last verified: 2013-11