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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 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.

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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

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

FieldValue
Enrollment Target 80 participants
Start Date 2011-08
Est. Completion 2020-08
Phase NA

Sponsor

Rush University Medical Center

320 total trials

What the Registry Record Tells You About NCT01373099

The ClinicalTrials.gov registry entry for NCT01373099 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 817-participant average among 135 other Osteoarthritis trials with a reported enrollment target (90% lower). The listed sponsor is Rush University Medical Center, which has 320 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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