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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: Completed NA study, sponsored by Rush University Medical Center.

NCT01373112 is a NA study that has completed, run by Rush University Medical Center. The registered enrollment target is 68 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 68 participants
Start Date 2011-12
Est. Completion 2020-08
Phase NA
Rush University Medical Center

320 total trials

What the finished NCT01373112 record still lists

NCT01373112 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 2 interventions - of which Static Spacer is the first listed.

NCT01373112 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01373112's enrollment target sits among peer trials

68 1133rd of 2000 higher than 862 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01373112, the US trial registry maintained by the National Library of Medicine. NCT01373112 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.