Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection
Public ClinicalTrials.gov record NCT06293352. 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.
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Official title
Durable, Real-component Antibiotic Spacers vs All-cement Articulating Spacers for the Treatment of Periprosthetic Knee Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
In the US, if an infection in an artificial knee joint doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, the surgeon will remove the artificial knee and clean out the area around the knee. They will then place an antibiotic spacer. An antibiotic spacer is a type of artificial joint that will release antibiotics into the knee space continuously over time. The spacer allows only very basic function of the knee. The patient may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, the surgeon may prescribe a course of antibiotics as well. Because the antibiotic spacer is not as durable as a regular artificial joint, after the infection is gone, another surgery is required to take the spacer out and put a new artificial knee joint in. There is another way for artificial joint infections to be treated. This is a one-stage revision. In this treatment, the surgeon will remove the artificial knee and clean out the area around the knee. Then the surgeon will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics into the knee space continuously over time (the surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as the original artificial knee. This means that while the infection is healing the patient will be able to do most of the regular daily activities. However, the antibiotic cement is not as durable as what is normally used to implant an artificial knee. The artificial knee with the antibiotic cement may need to be replaced with a regular artificial knee. When replacement will need to be done is dependent on patient weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, the patient will have another surgery where the surgeon will take the antibiotic cement artificial knee and put a new artificial knee joint in. Investigators know that both the one- and two-stage revision work equally well to heal the infection, but investigators don't know which patients prefer or which provides better function after many years. This study will randomly assign patients to receive either a one-stage or two-stage revision and then follow them for 5 years to ask them about pain, function, and satisfaction.
Study identification
- NCT ID
- NCT06293352
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Interventions
- All-cement articulating spacer Device
- Durable, real-component articulating spacer Device
- Rigid Spacer Device
Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Aug 7, 2024
- Primary completion
- Jul 31, 2027
- Completion
- Jul 31, 2028
- Last update posted
- Aug 23, 2026
2024 – 2028
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Northwestern Medicine | Chicago | Illinois | 60611 | Recruiting |
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 NCT06293352, 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 Aug 23, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06293352 live on ClinicalTrials.gov.