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

NCT06293352 | Recruiting FDA Device

• 1 other identifier: STU00220012
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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

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

Keywords

randomized trial; patient-reported outcomes

Outcome Measures

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.

  24 months after surgery

Secondary Outcomes (1)

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

  24 months after surgery

Other Outcomes (4)

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

  24 months after surgery

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

  24 months after surgery

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

  24 months after surgery

Study Arms (3)

All-cement articulating spacer

ACTIVE COMPARATOR

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.

Device: All-cement articulating spacer

Durable, real-component articulating spacer

ACTIVE COMPARATOR

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.

Device: Durable, real-component articulating spacer

Observation

OTHER

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.

Device: All-cement articulating spacer; Device: Durable, real-component articulating spacer; Device: Rigid Spacer

Interventions

All-cement articulating spacer DEVICE

Two-stage intervention

All-cement articulating spacer; Observation

Rigid Spacer DEVICE

Observation intervention

Observation

Durable, real-component articulating spacer DEVICE

Single stage intervention

Durable, real-component articulating spacer; Observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Extensor mechanism compromise

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Related Publications (1)

• Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.

  PMID: 29551303 BACKGROUND

Study Officials

• Adam I Edelstein, MD

  Assistant Professor of Orthopaedic Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa J Shauver, MPH

CONTACT

312-472-6024; melissa.shauver@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 5, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data available after publication of final publication.
• Access Criteria: By request.

Locations

US (1)