Back to resultsTreatment of Acute Periprosthetic Total Hip Arthroplasty Infections
Primary Purpose
Periprosthetic Infection Total Hip Arthoplasty
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
open debridement with modular exchange
one stage exchange
Sponsored by
About this trial
This is an interventional treatment trial for Periprosthetic Infection Total Hip Arthoplasty
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
Labs
- Rising inflammatory seromarkers
- Aspiration with a positive culture
Exclusion Criteria:
- 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
Sites / Locations
- OrthoCarolina Research Institue
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
open debridement with modular exchange
one stage exchange
Arm Description
Outcomes
Primary Outcome Measures
Success
Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection
Secondary Outcome Measures
Full Information
NCT ID
NCT01712880
First Posted
October 22, 2012
Last Updated
November 5, 2013
Sponsor
OrthoCarolina Research Institute, Inc.
Collaborators
Midwest Orthopaedics at Rush, University of California, San Francisco, Emory University
1. Study Identification
Unique Protocol Identification Number
NCT01712880
Brief Title
Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Why Stopped
The study was not feasible.
Study Start Date
October 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoCarolina Research Institute, Inc.
Collaborators
Midwest Orthopaedics at Rush, University of California, San Francisco, Emory University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periprosthetic Infection Total Hip Arthoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open debridement with modular exchange
Arm Type
Active Comparator
Arm Title
one stage exchange
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
open debridement with modular exchange
Intervention Type
Procedure
Intervention Name(s)
one stage exchange
Primary Outcome Measure Information:
Title
Success
Description
Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection
Time Frame
2 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Labs
- Rising inflammatory seromarkers
Aspiration with a positive culture
Exclusion Criteria:
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
Facility Information:
Facility Name
OrthoCarolina Research Institue
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections
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