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NCT01373112 · ClinicalTrials.gov registry record · NA
Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection
A NA study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 68
- Enrollment target
NCT01373112 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 68 participants.
The verdict
NCT01373112, a NA study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 68 participants
- Enrollment target
Study Summary
Infection remains a difficult-to-treat complication of total knee arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later replacement of permanent implants. The first stage consists of removal of the infected arthroplasty components and the surrounding devitalized tissue, copious pulsed irrigation, and placement of a temporary antibiotic-impregnated cement spacer. This spacer typically is left in place six weeks, during which time the patient receives intravenous antibiotics. After the surgeon feels that the infection has been eradicated, or if the patient requires repeat debridement, a second operative procedure is performed. While the use of an antibiotic-loaded spacer is well accepted, whether the spacer should immobilize the knee (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of articulating spacers argue that they prevent scarring of the musculature surrounding the knee resulting in easier reimplantation, improved long-term knee function, and improved range of motion. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and is simpler to fashion intraoperatively. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters knee function, operative time, and range of motion. Equipoise exists within the literature, and no randomized clinical trial has been conducted to evaluate this issue. The purpose of this study is to compare articulating and static antibiotic-impregnated spacers for the treatment of chronic periprosthetic infection complicating total knee arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, knee function, ease of reimplantation, and range of motion. The investigators hypothesize th
Interventions
- PROCEDURE Static Spacer
- PROCEDURE Articulating Spacer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2011-12 |
| Est. Completion | 2020-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01373112
The ClinicalTrials.gov registry entry for NCT01373112 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Static Spacer is the first listed.
NCT01373112 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01373112 about?
NCT01373112 is a clinical study titled "Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection". Infection remains a difficult-to-treat complication of total knee arthroplasty. The gold standard treatment is two-stage removal of the prosthesis with later replacement of permanent implants. The first stage consists of removal of the infected arthroplasty components and the surrounding devitalized...
What is the current status of trial NCT01373112?
This trial is currently completed. It is a NA study. The enrollment target is 68 participants. The study started on 2011-12. Estimated completion is 2020-08.
What interventions are being tested in trial NCT01373112?
The interventions under investigation include: Static Spacer (PROCEDURE), Articulating Spacer (PROCEDURE).
Who is sponsoring clinical trial NCT01373112?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
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