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NCT06293352 · ClinicalTrials.gov registry record · NA
Real-component Vs All-cement Articulating Spacers for Periprosthetic Knee Infection
A NA study of Arthroplasty, Replacement, Knee and Prosthetic-joint Infection, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 153
- Enrollment target
- 1
- Study location
NCT06293352: Recruiting NA study of Arthroplasty, Replacement, Knee and Prosthetic-joint Infection, sponsored by Northwestern University.
NCT06293352 is a NA study of Arthroplasty, Replacement, Knee and Prosthetic-joint Infection that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 153 participants, below the 190-participant average among 12 other Arthroplasty, Replacement, Knee trials with a reported enrollment target (19% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06293352, a NA study of Arthroplasty, Replacement, Knee and Prosthetic-joint Infection, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 153 participants
- Enrollment target
- 1
- Study location
Study Summary
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
Primary Outcome
Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Conditions Studied
Interventions
- DEVICE All-cement articulating spacer
- DEVICE Durable, real-component articulating spacer
- DEVICE Rigid Spacer
Study Locations (1)
Illinois
- Northwestern Medicine - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2024-08-08 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT06293352 shows while recruiting
NCT06293352 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 190-participant average among 12 other Arthroplasty, Replacement, Knee trials with a reported enrollment target (19% lower).
The record links to 5 conditions, with Arthroplasty, Replacement, Knee appearing as the primary indexed condition, and to 3 interventions - of which All-cement articulating spacer is the first listed.
NCT06293352 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT06293352 about?
NCT06293352 is a clinical study titled "Real-component Vs All-cement Articulating Spacers for Periprosthetic Knee Infection". 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 antibioti...
What is the current status of trial NCT06293352?
This trial is currently recruiting. It is a NA study. The enrollment target is 153 participants. The study started on 2024-08-08. Estimated completion is 2026-12.
What conditions does trial NCT06293352 study?
This clinical trial studies the following conditions: Arthroplasty, Replacement, Knee, Prosthetic-joint Infection, Joint Infection, Arthroplasty Complications, Knee Infection.
What interventions are being tested in trial NCT06293352?
The interventions under investigation include: All-cement articulating spacer (DEVICE), Durable, real-component articulating spacer (DEVICE), Rigid Spacer (DEVICE).
Who is sponsoring clinical trial NCT06293352?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06293352 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 NCT06293352's enrollment target sits among peer trials
153 5th of 12 higher than 8 of 12 other Arthroplasty, Replacement, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Arthroplasty, Replacement, Knee 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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