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/29551303/Actively Recruiting
Led by Northwestern University · Updated on 2026-03-24
153
Participants Needed
1
Research Sites
17 weeks
Total Duration
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
Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection
M
Melissa J Shauver, MPH
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Northwestern University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Durable, real-component articulating spacer | All-cement articulating spacer |
|---|---|---|
| What it is | A durable, real-component articulating spacer is implanted in a single-stage procedure after removal of the infected prosthesis for chronic periprosthetic knee infection. | A traditional two-stage surgical approach where an all-cement articulating spacer is placed after prosthesis removal to manage periprosthetic joint infection. |
| Role in the trial | Evaluated as the investigational procedure for possible functional and infection-control benefits in a randomized fashion. | Serves as the randomized comparator, representing current standard cement-based spacers for two-stage revision surgery. |
| Primary use | For surgical management of chronic periprosthetic joint infection, enabling stable joint articulation, local antibiotic delivery, and potential for single-stage restoration of knee function. | For surgical management of chronic periprosthetic joint infection, providing joint stability and local antibiotic delivery between prosthesis removal and final reimplantation. |
| How it is given or performed | The infected prosthesis is removed and replaced with an articulating spacer constructed from actual prosthetic components in a single operation, with the intent for durable function during infection control. | Surgery involves removal of the infected prosthesis, placement of an articulating spacer made entirely of antibiotic-loaded cement, a period of infection control, and a planned second surgery for definitive reimplantation. |
| Evidence status | Current evidence is limited; outcomes and benefits in terms of infection control and joint function are under investigation in this randomized trial. | Established method with mature evidence supporting its use for infection management in two-stage knee revision. Still used as a comparator in ongoing trials to investigate novel alternatives. |
| Important limitations | As an investigational approach, long-term outcomes and safety are not yet established. Potential concerns include unique surgical risks or mechanical issues related to using real prosthesis components as temporary spacers. | Potential limitations include limited knee motion and discomfort during the interstage period, mechanical complications, and the need for multiple surgeries. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Javad Parvizi, Timothy L Tan, Karan Goswami...
https://pubmed.ncbi.nlm.nih.gov/29551303/Northwestern University
Lead Sponsor