Articulating Spacers for Knee Infections

N/A

Recruiting

Led By Adam I Edelstein, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months after surgery

Awards & highlights

No Placebo-Only Group

Summary

"This trial is comparing two different treatments for artificial knee joint infections. The standard treatment involves two surgeries - first to remove the artificial knee and place an antibiotic spacer, and a second surgery to replace the spacer

Who is the study for?

This trial is for patients with a chronic infection in their artificial knee joint after initial replacement surgery, who are planning to have the infected joint replaced with an antibiotic spacer. They must meet specific infection criteria and be able to consent. Those with allergies to study materials, soft tissue or bone issues at the site can't participate.

What is being tested?

The study compares two treatments for infected knee replacements: one-stage revision using a special cement that releases antibiotics, allowing near-normal activity but may need future replacement; versus two-stage revision which uses a temporary spacer then later surgery for durable joint placement.

What are the potential side effects?

Potential side effects include reactions to the antibiotic-releasing materials such as irritation or allergy, complications from reduced durability of the cement leading to earlier-than-expected need for another surgery, and general risks associated with surgical procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months after surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

24 month Knee Injury and Osteoarthritis Outcome - Joint Replacement Score (KOOS-JR)

Secondary study objectives

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

Other study objectives

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

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

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

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: ObservationExperimental Treatment3 Interventions

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.

Group II: All-cement articulating spacerActive Control1 Intervention

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.

Group III: Durable, real-component articulating spacerActive Control1 Intervention

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.

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