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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06293352
Status
Recruiting
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Conditions

  • Arthroplasty Complications
  • Arthroplasty, Replacement, Knee
  • Joint Infection
  • Knee Infection
  • Prosthetic-joint Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • All-cement articulating spacer — DEVICE
    Two-stage intervention
  • Durable, real-component articulating spacer — DEVICE
    Single stage intervention
  • Rigid Spacer — DEVICE
    Observation intervention

Study Details

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.

Key Dates

Start date
Aug 8, 2024
Status verified
Mar 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: All-cement articulating spacer
    An articulating spacer with a tibial and femoral component made of cement using molds, that are cemented in place; use of highdose antibiotic cement (at least 2g/batch, including vancomycin and tobramycin); use of dowels at discretion of surgeon; 6 weeks IV antibiotics; intent to reimplant definitive prosthesis if infection eradicated.
  • Active Comparator: Durable, real-component articulating spacer
    Uses metal (or ceramicized metal) on plastic for bearing surface; use of high-dose antibiotic cement (at least 2g/batch, including vancomycin and tobramycin); no cones/sleeves, no pressurized cement in canal; use of stems/dowels/augments and level of constraint at discretion of surgeon; 6 weeks IV antibiotics; intent to leave in situ indefinitely/until clinical failure.
  • Other: Observation
    Patients who do not wish to be randomized or who meet the randomization-specific exclusion criteria will be offered enrolment into the non-randomized, prospective observational arm of the study. The participant and their surgeon will collaboratively decide which of the 2 treatments the participant will receive.

Primary Outcome Measure

24 month Knee Injury and Osteoarthritis Outcome - Joint Replacement Score (KOOS-JR) [ Time Frame: 24 months after surgery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern MedicineChicagoIllinois60611
Orthopaedic Surgery Research
[email protected]
312-695-0332
Adam I Edelstein, MD (PRINCIPAL_INVESTIGATOR)
Kevin D Hardt, MD (SUB_INVESTIGATOR)
Linda I Suleiman, MD (SUB_INVESTIGATOR)
David W Manning, MD (SUB_INVESTIGATOR)
William C Thomas, MD (SUB_INVESTIGATOR)

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By research site
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