Knee InfectionNCT04446676
Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
A study testing stabilization with stem and stabilization with sleeve in people with Knee Infection, run by Prof A Gruca Teaching Hospital at 1 site in Poland.
Trial summary
Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Infection
- What is being tested?
- stabilization with stem and stabilization with sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 17 Nov 2020to Jan 2027
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- second-stage of knee reimplantation
- primary knee replacement in primary knee osteoarthritis
- fulfillment of International Consensus Meeting 2018 infection criteria
Who cannot join
- intraoperative bone defects Anderson Orthopedic Research Institute score >II
- autoimmune disease
- diabetes
- peripheral vascular disease
- congenital or acquired immunodeficiencies
- lack of pathogens after first-stage
Show all 9Show fewer
- multi-bacterial infection
- multidirectional instability
- lack of patient consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Gruca Teaching Hospital, Centre of Postgraduate Medical Centre
Otwock, Masovian Voivodeship, 05-400
Paweł Bartosz, +48 793629685, pbartosz@vp.pl
About this study
Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.
Read the detailed description
All participants will be treated because of periprosthetic joint infection of the knee, after primary arthroplasty. All participants will be treated with two-stage protocol. In first stage debridement and spacer implantation will be performed. After 6-week antibiotics, when will be absent clinical or laboratory signs of reinfection, second stage will be performed. All participants upon fulfillment all inclusion and exclusion criteria will sign informed consent. With computer software patients will be randomized to one of two groups: with stem vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks. Pre-operation and after on periodic controls will checked the Knee Society Score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After 2-year observation evaluation of reinfection rate will be performed in both groups.
- Conditions
- Knee Infection
- Being tested
- stabilization with stem, stabilization with sleeve
- Keywords
- knee arthroplasty, infection, two-stage, sleeve, stem
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stabilization with stemDevice
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
stabilization with sleeveDevice
In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
| Study group | Role | What they receive |
|---|---|---|
| Stem stabilization | Active comparator | Group of patients with stem endoprosthesis stabilization Receives: Device: stabilization with stem |
| Sleeve stabilization | Active comparator | Group of patients with sleeve endoprosthesis stabilization Receives: Device: stabilization with sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinfection
Rate of reinfection in both groups
Measured: 2 years
Secondary outcomes (1)
Loosening radiological signs
Radiological evaluation of implant loosening with Modern Knee Society Radiographic Evaluation System
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start17 Nov 2020
- Primary completionJul 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee InfectionStudies of the same condition, open and under way.
- 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
- Model description
- Two groups with endoprosthesis stabilisation with stem or sleeve.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prof A Gruca Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bartosz Paweł, Prof A Gruca Teaching Hospital
- Investigators
- Paweł Bartosz, Principal investigator, Prof. A. Gruca Teaching Hospital in Otwock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446676
- Sponsor's protocol ID
- Gruca Teaching Hospital
- Status last verified
- Mar 2022
- First submitted
- 21 Jun 2020
- Last updated
- 15 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol and Informed consent form will be shared
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Type of Stabilization in the Two-stage Knee Reimplantation on Reinfection - Prospective, Randomized Study.
- ClinicalTrials.gov ID
- NCT04446676
- Acronym / sponsor ID
- Gruca Teaching Hospital
- Conditions
- Knee Infection
- Keywords
- knee arthroplasty, infection, two-stage, sleeve, stem
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Prof A Gruca Teaching HospitalUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 25 Jun 2020 (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.
Participants after first-stage of knee infection reimplantation will be assign to one of two groups: with stem vs. with sleeve. Investigators will check participants on clinical, laboratory and reinfection signs. The main hypothesis is that better mechanical stability of endoprosthesis with sleeves will support infection treatment.
Detailed description
All participants will be treated because of periprosthetic joint infection of the knee, after primary arthroplasty. All participants will be treated with two-stage protocol. In first stage debridement and spacer implantation will be performed. After 6-week antibiotics, when will be absent clinical or laboratory signs of reinfection, second stage will be performed. All participants upon fulfillment all inclusion and exclusion criteria will sign informed consent. With computer software patients will be randomized to one of two groups: with stem vs. with sleeve. After operation all patients will get target antibiotics for 3 weeks. Pre-operation and after on periodic controls will checked the Knee Society Score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC), Visual Analogue Scale. After 2-year observation evaluation of reinfection rate will be performed in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two groups with endoprosthesis stabilisation with stem or sleeve.
| Arm | Type | Receives |
|---|---|---|
| Stem stabilization | Active comparator | Device: stabilization with stemGroup of patients with stem endoprosthesis stabilization |
| Sleeve stabilization | Active comparator | Device: stabilization with sleeveGroup of patients with sleeve endoprosthesis stabilization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- second-stage of knee reimplantation
- primary knee replacement in primary knee osteoarthritis
- fulfillment of International Consensus Meeting 2018 infection criteria
Key exclusion criteria (9 listed)
- intraoperative bone defects Anderson Orthopedic Research Institute score >II
- autoimmune disease
- diabetes
- peripheral vascular disease
- congenital or acquired immunodeficiencies
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 |
|---|---|---|
| stabilization with stemIn both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization. | Device | Stem stabilization |
| stabilization with sleeveIn both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization. | Device | Sleeve stabilization |
Primary outcome
Reinfection
Time frame: 2 years
Rate of reinfection in both groups
1 secondary outcome
Loosening radiological signs
Time frame: 2 years
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 15 Mar 2022.
- Individual participant dataSharing planned: Yes. Study protocol and Informed consent form will be shared
Related trials for Knee Infection
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Sola2 AMF Knee System Added to Surgery and Antibiotics in Adults With Knee Implant Infection
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A Phase 2b Study to Evaluate the Efficacy, Safety, and PK Profiles of TNP-2092 Administered Via IA Injection in PJI Participants
Prosthetic Joint Infection (PJI)
RecruitingPhase 2/3
Evaluation of PLG0206 in Prevention of Recurrent Infection in Patients Undergoing Debridement, Antibiotics, and Implant Retention (DAIR) for Treatment of a Periprosthetic Joint Infection (PJI) Following Knee Arthroplasty
Prosthetic-joint Infection
Not yet recruitingObservational study
oneKNEE - Prospective, Non-interventional, Multicenter PMCF-Study
Arthroplasty, Arthroplasty Replacement, Knee
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CLinical Evaluation of ANtiseptic Skin Preparation in Revision Total Joint Arthroplasty of the Hip and Knee
Revision Total Hip Arthroplasty (RTHA), Revision Total Knee Arthroplasty
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.
Paweł Bartosz principal investigator
Prof. A. Gruca Teaching Hospital in Otwock
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stabilization with stem and stabilization with sleeve in people with Knee Infection, run by Prof A Gruca Teaching Hospital at 1 site in Poland.
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 3 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 15 Mar 2022. 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 Poland. 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 Paweł Bartosz (+48 793629685, pbartosz@vp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reinfection (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Mar 2022.