RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Durable, Real-component Antibiotic Spacers Vs All-cement Articulating Spacers for the Treatment of Periprosthetic Knee Infection

Quick Facts

Study Start:2024-08-08
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06293352

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed with a chronic periprosthetic joint infection after a primary total knee arthroplasty with plan for explant and placement of an antibiotic spacer
  2. * PJI defined according to Musculoskeletal Infection Society (MSIS) 2018 Consensus Criteria
  1. * Patients who are unable to consent
  2. * Infection at site of revision TKA
  3. * Soft tissue envelope compromise
  4. * Allergies to study materials (cement, vancomycin, tobramycin)
  5. * Incompetent extensor mechanism
  6. * Extensive bone loss
  7. * Extensive soft tissue defect
  8. * Extensor mechanism compromise

Contacts and Locations

Study Contact

Melissa J Shauver, MPH
CONTACT
312-472-6024
melissa.shauver@northwestern.edu

Principal Investigator

Adam I Edelstein, MD
PRINCIPAL_INVESTIGATOR
Assistant Professor of Orthopaedic Surgery

Study Locations (Sites)

Northwestern Medicine
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Northwestern University

  • Adam I Edelstein, MD, PRINCIPAL_INVESTIGATOR, Assistant Professor of Orthopaedic Surgery

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-08
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-08-08
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • randomized trial
  • patient-reported outcomes

Additional Relevant MeSH Terms

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