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

February 28, 2024 updated by: Adam Edelstein, Northwestern University

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

In the US, if you get an infection in your artificial knee joint that doesn't heal with antibiotics alone, the standard treatment is a two-stage revision of the artificial knee. In the first stage, your surgeon will remove your 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 in to the knee space continuously over time. The spacer allows only very basic function of the knee. You may need to use crutches or a walker while the antibiotic spacer is in place. After surgery to place the antibiotic spacer, your 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 your artificial knee and clean out the area around the knee. Then they will place a new artificial knee in using a special kind of cement that contains antibiotics. The cement will release antibiotics in to the knee space continuously over time (your surgeon may prescribe a course of antibiotics as well). The new artificial joint with antibiotic cement will function almost the same as your original artificial knee. This means that while the infection is healing you will be able to do most of your 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 your weight, bone strength and activity level, among other things. When it is time to replace the antibiotic cement artificial knee, you will have another surgery where the surgeon will take the antibiotic cement artificial knee and but a new artificial knee joint in.

We know that both the one- and two-stage revision work equally well to heal the infection, but we 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study compares to currently used treatments for chronic peri-prosthetic joint infections: Treatment with an all-cement articulating spacer and treatment with a durable, real-component articulating spacer.

An all-cement articulating spacer will be defined as follows: An articulating spacer with a tibial and femoral component made of cement using molds, that are cemented in place; use of high-dose 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.

A durable, real-component articulating spacer will be defined as follows: 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.

This will be a study with 2 cohorts. We will have a randomized cohort, as well as a nonrandomized prospective observational cohort.

Surgery will be performed by current treatment guidelines in the same manner as if the patient was not in a research study.

All questionnaires will be administered via iPad/online.

The questionnaires administered at the preoperative appointment will consist preoperative patient-reported outcomes (PROs). The preoperative PROs will be determined utilizing PROMIS questionnaires including PROMI-10 Survey and the Knee Injury and Osteoarthritis Outcome Score (KOOS-12), In addition, patient demographic characteristics will be collected including age, sex, race, education and insurance status as well as self-reported comorbidity data.

The questionnaires will be administered again at the 6-week and 6-month, 12-month, and 24- month postoperative time points. In addition, the PROMIS depression scale will be collected at 6 weeks.

The presence and absence any complications, along with complication severity as determined by the PI, during the procedure or during recovery will be extracted from the EMR by the PI and/or Co-investigator after surgery and after every postoperative visit through the 24-month visit.

Study Type

Interventional

Enrollment (Estimated)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Medicine
        • Contact:
        • Principal Investigator:
          • Adam I Edelstein, MD
        • Sub-Investigator:
          • Kevin D Hardt, MD
        • Sub-Investigator:
          • Linda I Suleiman, MD
        • Sub-Investigator:
          • David W Manning, MD
        • Sub-Investigator:
          • William C Thomas, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: All-cement articulating spacer
Two-stage intervention
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.
Device: Durable, real-component articulating spacer
Single stage intervention
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.
Device: All-cement articulating spacer
Two-stage intervention
Device: Durable, real-component articulating spacer
Single stage intervention
Device: Rigid Spacer
Observation intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24 month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 24 months after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 week Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 weeks after surgery
Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
6 weeks after surgery
6 week 10-item PROMIS Global Health survey (PROMIS-10)
Time Frame: 6 weeks after surgery
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.
6 weeks after surgery
6 month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 6 months after surgery
Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
6 months after surgery
6 month 10-item PROMIS Global Health survey (PROMIS-10)
Time Frame: 6 months after surgery
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.
6 months after surgery
12 month Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: 12 months after surgery
Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
12 months after surgery
12 month 10-item PROMIS Global Health survey (PROMIS-10)
Time Frame: 12 months after surgery
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.
12 months after surgery
24 month 10-item PROMIS Global Health survey (PROMIS-10)
Time Frame: 24 months after surgery
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.
24 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Revision/reoperation for infection (defined by positive culture by MSIS criteria)
Time Frame: 24 months after surgery
Count and percentage of occurrence of revision/reoperation for infection
24 months after surgery
revision for aseptic failure (defined by negative culture by MSIS criteria)
Time Frame: 24 months after surgery
Count and percentage of occurrence of reoperation for aseptic failure
24 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Adam I Edelstein, MD, Assistant Professor of Orthopaedic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 5, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 28, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00220012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Open to data sharing by request.

IPD Sharing Time Frame

Data available after publication of final publication.

IPD Sharing Access Criteria

By request.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Arthroplasty, Replacement, Knee

Clinical Trials on All-cement articulating spacer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe