Recruiting

Real-component vs. All-cement

Sponsor:

Northwestern University

Code:

NCT06293352

Conditions

Prosthetic-joint Infection

Knee Infection

Arthroplasty Complications

Joint Infection

Arthroplasty, Replacement, Knee

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

All-cement articulating spacer

Durable, real-component articulating spacer

Rigid Spacer

Study Details

Brief 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 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

Prosthetic-joint Infection

Knee Infection

Arthroplasty Complications

Joint Infection

Arthroplasty, Replacement, Knee

Study ID

NCT06293352

Start date

Aug 8, 2024

Status verified date

Aug, 2026

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Randomization-specific exclusion criteria

  • Extensive soft tissue defect
  • Extensor mechanism compromise

Study Design

Enrollment

153 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

All-cement articulating spacer

Two-stage intervention

Durable, real-component articulating spacer

Single stage intervention

Rigid Spacer

Observation intervention

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Northwestern Medicine

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Orthopaedic Surgery Research

312-695-0332orthosurveys@nm.org

Principal Investigator:

Adam I Edelstein, MD

More Information

Sponsor

Northwestern University

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Keywords

  • randomized trial
  • patient-reported outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-08-24.