Articulating Versus Static Antibiotic Loaded Spacers for the Treatment of Prosthetic Knee Infection
Public ClinicalTrials.gov record NCT01373112. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 that articulating spacers will provide shorter operative times at reimplantation, while improving knee function and range of motion.
Study identification
- NCT ID
- NCT01373112
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 68 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2011
- Primary completion
- Jul 31, 2020
- Completion
- Jul 31, 2020
- Last update posted
- Oct 7, 2020
2011 – 2020
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01373112, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2020 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01373112 live on ClinicalTrials.gov.