Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06293352

Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection

Led by Northwestern University · Updated on 2026-03-24

153

Participants Needed

1

Research Sites

120 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with a chronic periprosthetic joint infection after a primary total knee arthroplasty with plan for explant and placement of an antibiotic spacer
  • PJI defined according to Musculoskeletal Infection Society (MSIS) 2018 Consensus Criteria
Not Eligible

You will not qualify if you...

  • Patients who are unable to consent
  • Infection at site of revision TKA
  • Soft tissue envelope compromise
  • Allergies to study materials (cement, vancomycin, tobramycin)
  • Incompetent extensor mechanism
  • Extensive bone loss
  • Extensive soft tissue defect (randomization-specific exclusion)
  • Extensor mechanism compromise (randomization-specific exclusion)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwestern Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

M

Melissa J Shauver, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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