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NCT01373099 · ClinicalTrials.gov registry record · NA
Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement
A NA study of Osteoarthritis and Prosthetic-joint Infection, sponsored by Rush University Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT01373099: Completed NA study of Osteoarthritis and Prosthetic-joint Infection, sponsored by Rush University Medical Center.
NCT01373099 is a NA study of Osteoarthritis and Prosthetic-joint Infection that has completed, run by Rush University Medical Center. The registered enrollment target is 80 participants, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01373099, a NA study of Osteoarthritis and Prosthetic-joint Infection, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
Infection remains one of the most difficult-to-treat complications of total hip 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 is typically 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 a second debridement is required, a second operative procedure is performed. While the use of an antibiotic spacer is well accepted, whether the spacer should immobilize the hip (a so-called "static" spacer) or allow for range of motion (a so-called "articulating" spacer) is controversial. Proponents of static spacers argue that immobilization of the periarticular soft tissues aids in clearance of the infection and that these spacers are simpler to fashion intraoperatively. Proponents of articulating spacers argue that they improve hip function, prevent damage to the musculature surrounding the hip, allow easier reimplantation, improve hip function, and prevent dislocation following hip reimplantation. While good results have been described with both methods, comparative trials have been conflicting as to whether spacer design alters hip function, operative time, and dislocation rates. 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 hip arthroplasty through a prospective, randomized clinical trial. The goals of this trial are to determine the effect of spacer design upon eradication of infection, hip function, ease of reimplantation, and disloca
Primary Outcome
The Harris Hip score has been used extensively in the study of revision hip arthroplasty and has been found to be reliable and valid to determine hip arthroplasty outcomes.
Conditions Studied
Interventions
- PROCEDURE Implantation of a static, non-articulating cement spacer.
- PROCEDURE Implantation of an articulating spacer.
Study Locations (1)
Illinois
- Rush University Medical Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2011-08 |
| Est. Completion | 2020-08 |
| Phase | NA |
What the finished NCT01373099 record still lists
NCT01373099 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (90% lower).
The record links to 5 conditions, with Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Implantation of a static, non-articulating cement spacer. is the first listed.
NCT01373099 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT01373099 about?
NCT01373099 is a clinical study titled "Study of Antibiotic Spacer Design to Treat Infection After Hip Replacement". Infection remains one of the most difficult-to-treat complications of total hip 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 surroundin...
What is the current status of trial NCT01373099?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2011-08. Estimated completion is 2020-08.
What conditions does trial NCT01373099 study?
This clinical trial studies the following conditions: Osteoarthritis, Prosthetic-joint Infection, Complications; Arthroplasty, Hip Infection, Complications; Arthroplasty, Infection or Inflammation.
What interventions are being tested in trial NCT01373099?
The interventions under investigation include: Implantation of a static, non-articulating cement spacer. (PROCEDURE), Implantation of an articulating spacer. (PROCEDURE).
Who is sponsoring clinical trial NCT01373099?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01373099 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01373099's enrollment target sits among peer trials
80 99th of 135 higher than 35 of 135 other Osteoarthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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