Prosthetic-joint InfectionNCT06293352
Real-component vs All-cement Articulating Spacers for Periprosthetic Knee Infection
A study testing All-cement articulating spacer, Durable, real-component articulating spacer and Rigid Spacer in people with Prosthetic-joint Infection and Knee Infection, run by Northwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prosthetic-joint Infection, Knee Infection, Arthroplasty Complications
- What is being tested?
- All-cement articulating spacer, Durable, real-component articulating spacer and Rigid Spacer
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2024to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Randomization-specific exclusion criteria
- Extensive soft tissue defect
- Extensor mechanism compromise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern Medicine
Chicago, Illinois, 60611
Orthopaedic Surgery Research, 312-695-0332, orthosurveys@nm.org
Adam I Edelstein, MD
About this study
Official title: Durable, Real-component Antibiotic Spacers vs All-cement Articulating Spacers for the Treatment of Periprosthetic Knee Infection
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.
Read the 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 - Joint Replacement Score (KOOS-JR), 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.
- Conditions
- Prosthetic-joint Infection, Knee Infection, Arthroplasty Complications, Joint Infection, Arthroplasty, Replacement, Knee
- Being tested
- All-cement articulating spacer, Durable, real-component articulating spacer, Rigid Spacer
- Keywords
- randomized trial, patient-reported outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All-cement articulating spacerDevice
Two-stage intervention
Durable, real-component articulating spacerDevice
Single stage intervention
Rigid SpacerDevice
Observation intervention
| Study group | Role | What they receive |
|---|---|---|
| All-cement articulating spacer | Active comparator | 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. Receives: Device: All-cement articulating spacer |
| Durable, real-component articulating spacer | Active comparator | 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. Receives: Device: Durable, real-component articulating spacer |
| Observation | Other | 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. Receives: Device: All-cement articulating spacer; Device: Durable, real-component articulating spacer; Device: Rigid Spacer |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 month Knee Injury and Osteoarthritis Outcome - Joint Replacement Score (KOOS-JR)
Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Measured: 24 months after surgery
Secondary outcomes (1)
24 month 10-item PROMIS Global Health survey (PROMIS-10)
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.
Measured: 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start8 Aug 2024
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthetic-joint InfectionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 153 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Edelstein, Northwestern University
- Investigators
- Adam I Edelstein, MD, Principal investigator, Assistant Professor of Orthopaedic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293352
- Sponsor's protocol ID
- STU00220012
- Status last verified
- Aug 2026
- First submitted
- 28 Feb 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Open to data sharing by request.
Publications
Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.
PubMed 29551303
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Durable, Real-component Antibiotic Spacers vs All-cement Articulating Spacers for the Treatment of Periprosthetic Knee Infection
- ClinicalTrials.gov ID
- NCT06293352
- Acronym / sponsor ID
- STU00220012
- Conditions
- Prosthetic-joint Infection, Knee Infection, Arthroplasty Complications, Joint Infection, Arthroplasty, Replacement, Knee
- Keywords
- randomized trial, patient-reported outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 153 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 - Joint Replacement Score (KOOS-JR), 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| All-cement articulating spacer | Active comparator | Device: All-cement articulating spacerAn 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. |
| Durable, real-component articulating spacer | Active comparator | Device: Durable, real-component articulating spacerUses 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. |
| Observation | Other | Device: All-cement articulating spacer, Device: Durable, real-component articulating spacer, Device: Rigid SpacerPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| All-cement articulating spacerTwo-stage intervention | Device | All-cement articulating spacer, Observation |
| Durable, real-component articulating spacerSingle stage intervention | Device | Durable, real-component articulating spacer, Observation |
| Rigid SpacerObservation intervention | Device | Observation |
Primary outcome
24 month Knee Injury and Osteoarthritis Outcome - Joint Replacement Score (KOOS-JR)
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.
1 secondary outcome
24 month 10-item PROMIS Global Health survey (PROMIS-10)
Time frame: 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Background: PubMed 29551303Parvizi J, Tan TL, Goswami K, Higuera C, Della Valle C, Chen AF, Shohat N. The 2018 Definition of Periprosthetic Hip and Knee Infection: An Evidence-Based and Validated Criteria. J Arthroplasty. 2018 May;33(5):1309-1314.e2. doi: 10.1016/j.arth.2018.02.078. Epub 2018 Feb 26.
- Individual participant dataSharing planned: Yes. Open to data sharing by request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam I Edelstein, MD principal investigator
Assistant Professor of Orthopaedic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing All-cement articulating spacer, Durable, real-component articulating spacer and Rigid Spacer in people with Prosthetic-joint Infection and Knee Infection, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa J Shauver, MPH (312-472-6024, melissa.shauver@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 month Knee Injury and Osteoarthritis Outcome - Joint Replacement Score (KOOS-JR) (time frame: 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06293352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.