The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria.
Javad Parvizi, Timothy L Tan, Karan Goswami...
https://pubmed.ncbi.nlm.nih.gov/29551303Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06293352
Durable, Real-component Antibiotic Spacers versus All-cement Articulating Spacers for Treating Periprosthetic Knee Infection
Led by Northwestern University · Updated on 2026-03-24
153
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for chronic infections in artificial knee joints, which sometimes do not heal with antibiotics alone. The study compares two common surgical approaches: the traditional two-stage revision using an all-cement articulating spacer and a newer single-stage revision using a durable, real-component articulating spacer. Both methods involve removing the infected joint and cleaning the area, but their long-term impact on patient function and satisfaction is not fully known. The two-stage revision involves placing an all-cement spacer that releases antibiotics and requires later surgery to implant a new artificial knee. The single-stage revision replaces the infected joint with a new artificial knee fixed with antibiotic cement intended to remain in place until clinical failure. Both treatments include a 6-week course of intravenous antibiotics. Patients will be randomly assigned to receive either spacer type or may choose treatment in an observational arm. Participants will complete questionnaires about pain, knee function, and overall health before surgery and at 6 weeks, 6 months, 12 months, and 24 months after surgery. Researchers will also track any complications during and after surgery through medical records. The main outcome measured is knee function at 24 months using the Knee Injury and Osteoarthritis Outcome - Joint Replacement Score (KOOS-JR). The study will follow participants for up to five years to assess pain, function, and satisfaction.
CONDITIONS
Brief Title
Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with a chronic periprosthetic joint infection after primary total knee arthroplasty with planned removal and antibiotic spacer placement
- Infection defined by Musculoskeletal Infection Society (MSIS) 2018 Consensus Criteria
- Adults aged 18 years and older
- Able to provide informed consent
You will not qualify if you...
- Unable to provide consent
- Infection at site of revision total knee arthroplasty
- Compromised soft tissue around the knee
- Allergies to cement, vancomycin, or tobramycin
- Dysfunctional knee extensor mechanism
- Extensive bone loss
- Extensive soft tissue defects (randomization-specific exclusion)
- Extensor mechanism compromise (randomization-specific exclusion)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - Day of surgery
Participants undergo surgery to receive either a durable, real-component articulating spacer or an all-cement articulating spacer according to current treatment guidelines.
1 surgical visit (in-person)
Treatment
Duration - 6 weeks
Participants receive 6 weeks of intravenous antibiotics following surgery while the spacer is in place.
Multiple visits during 6 weeks for IV antibiotic administration and monitoring
Post-operative Follow-up
Duration - 24 months
Participants complete patient-reported outcome questionnaires and clinical assessments at multiple time points to monitor recovery and complications.
Visits at 6 weeks, 6 months, 12 months, and 24 months post-surgery including questionnaire assessments
Trial Site Locations
Total: 1 location
1
Northwestern Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
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Research Team
M
Melissa J Shauver, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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