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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who are unable to consent

Infection at site of revision TKA

Soft tissue envelope compromise

Allergies to study materials (cement, vancomycin, tobramycin)

Trial design

Design model

Parallel

Treatments tested in this trial

  • All-cement articulating spacer

    Device

    Two-stage intervention

  • Durable, real-component articulating spacer

    Device

    Single stage intervention

  • Rigid Spacer

    Device

    Observation intervention

Treatment groups

153 Participants
are divided into 3 treatment groups
Group A: All-cement articulating spacerActive comparator 1 intervention
Group B: Durable, real-component articulating spacerActive comparator 1 intervention
Group C: ObservationOther 3 interventions

Trial outcomes

Primary outcomes

1

24 month Knee Injury and Osteoarthritis Outcome - Joint Replacement Score (KOOS-JR)

Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

Time frame
24 months after surgery

Secondary outcomes

1

24 month 10-item PROMIS Global Health survey (PROMIS-10)

Raw PROMIS-10 (v1.0) scores for Physical Health (PH) and Mental Health (MH) will be converted to standardized T-score values. A T-score of 50 represents the mean of the general population and higher scores indicate better physical or mental health.

Time frame
24 months after surgery

Other outcomes

1

Revision/reoperation for infection incidence (defined by positive culture by MSIS criteria)

Count of occurrence of revision/reoperation for infection

Time frame
24 months after surgery
2

Revision/reoperation for infection proportion (defined by positive culture by MSIS criteria)

Percentage of occurrence of revision/reoperation for infection

Time frame
24 months after surgery
3

Revision for aseptic failure incidence (defined by negative culture by MSIS criteria)

Count of occurrence of reoperation for aseptic failure

Time frame
24 months after surgery
4

Revision for aseptic failure proportion (defined by negative culture by MSIS criteria)

Percentage of occurrence of reoperation for aseptic failure

Time frame
24 months after surgery

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