Hip Prosthesis InfectionPhase 4NCT03389646
CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
A Phase 4 study testing CERAMENT G V in people with Hip Prosthesis Infection and Knee Prosthesis Infection, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hip Prosthesis Infection, Knee Prosthesis Infection
- What is being tested?
- CERAMENT G V
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteItaly
- Study dates
- 27 Sep 2017to 27 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent obtained prior to any study related procedure.
- Male or female age ≥ 18 and ≤ 85 years.
- Patients diagnosed with aseptic prosthetic loosening and scheduled for a one-stage hip or knee cementless or hybrid revision prosthesis implantation
- Patients with an interval spacer and scheduled for hip or knee cementless or hybrid revision prosthesis implantation.
- For those patients with an interval spacer, previous infection caused by microorganism(s) sensitive to gentamicin or vancomycin.
- Able (in the Investigators opinion) and willing to comply with all study requirements
Who cannot join
- Unable to give written informed consent.
- Medically unfit for operative intervention.
- Soft-tissue defects that prevent direct skin closure at revision surgery.
- Females who are pregnant or lactating.
- Females of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions may be included.
- Known allergy to gentamicin or vancomycin (or related antibiotics).
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- Patients with previous nephro- or ototoxicity events due to aminoglycoside and/or vancomycin (or glycopeptides) use.
- Presence of relevant contraindications as described in the EU CE mark Instructions for Use (IFU).
- Myasthenia gravis.
- Need of a fully cemented joint prosthesis.
- Psychiatric or neurological disorders.
- Active infection at the site of surgery as diagnosed by clinical and/or laboratory and/or imaging investigations.
- -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs Galeazzi
Milan
CARLO L ROMANO, MD, +39026621441 ext. 907, carlo.romano@grupposandonato.it
About this study
Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening.
The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM|G or V for the same indication.
Read more
Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice.
Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.
- Being tested
- CERAMENT G V
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CERAMENT G VDevice
During the removal of hip and knee prostheses usually bone defects occur at the intramedullary canal of the tibia and or / femur and /or acetabulum. These bone defects are filled with CERAMENTTM|G or V during the re-implantation of the cementless or hybrid revision THA or TKA. CERAMENTTM|G or V can be directly injected into the intramedullary canal or bone defect at the acetabulum. Alternatively and preferably, the surface of the prostheses shafts can be used to transfer CERAMENTTM|G or V into the bone defects. For information of handling and mixing please see the attached instructions for use (IFU).
| Study group | Role | What they receive |
|---|---|---|
| Treated with Device: Including sham | Active comparator | Treated with CERAMENTTM|G or V for filling of bone defects in the tibia and/or femur and/or the acetabulum. Receives: Device: CERAMENT G V |
| Control | No intervention | Control without CERAMENT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of post-surgical infection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start27 Sep 2017
- Primary completion27 Sep 2018 (estimated)
- Study completion27 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Prosthesis InfectionStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective with retrospective matched controls.
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CARLO L ROMANO, MD, Principal investigator, IRCCS GALEAZZI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389646
- Sponsor's protocol ID
- RAI2017
- Status last verified
- Dec 2017
- First submitted
- 26 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
- ClinicalTrials.gov ID
- NCT03389646
- Acronym / sponsor ID
- RAI2017
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 27 Sep 2018 (estimated)
- Study completion
- 27 Sep 2019 (estimated)
- First posted
- 3 Jan 2018 (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.
Open-label, multicentre, prospective cohort, observational clinical trial with a retrospective control group to evaluate the effectiveness and safety of CERAMENTTM| G or V used for filling of bone defects in the tibia and / or femur shaft and/or acetabulum in patients scheduled for two-stage hip or knee prosthesis re-implantation for PJI or aseptic loosening.
The results will be compared to a cohort of patients, which have been treated before the introduction of CERAMENTTM|G or V for the same indication.
Due to the observational character of the study, there will be no patient randomization and the clinicians in the study will remain entirely free to decide on the treatment of the patients according to established clinical practice.
Only patients for whom therapeutic strategy for the use of the product for filling bone defects is already planned according to local clinical practice, at the time of informed consent form signature, will be enrolled in this study. Thus, the decision for the choice of the surgical treatment, will not be influenced by the inclusion of the patient in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective with retrospective matched controls.
| Arm | Type | Receives |
|---|---|---|
| Treated with Device: Including sham | Active comparator | Device: CERAMENT G VTreated with CERAMENTTM|G or V for filling of bone defects in the tibia and/or femur and/or the acetabulum. |
| Control | No intervention | –Control without CERAMENT device |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written informed consent obtained prior to any study related procedure.
- Male or female age ≥ 18 and ≤ 85 years.
- Patients diagnosed with aseptic prosthetic loosening and scheduled for a one-stage hip or knee cementless or hybrid revision prosthesis implantation
- Patients with an interval spacer and scheduled for hip or knee cementless or hybrid revision prosthesis implantation.
- For those patients with an interval spacer, previous infection caused by microorganism(s) sensitive to gentamicin or vancomycin.
Key exclusion criteria (13 listed)
- Unable to give written informed consent.
- Medically unfit for operative intervention.
- Soft-tissue defects that prevent direct skin closure at revision surgery.
- Females who are pregnant or lactating.
- Females of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions may be included.
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 |
|---|---|---|
| CERAMENT G VDuring the removal of hip and knee prostheses usually bone defects occur at the intramedullary canal of the tibia and or / femur and /or acetabulum. These bone defects are filled with CERAMENTTM|G or V during the re-implantation of the cementless or hybrid revision THA or TKA. CERAMENTTM|G or V can be directly injected into the intramedullary canal or bone defect at the acetabulum. Alternatively and preferably, the surface of the prostheses shafts can be used to transfer CERAMENTTM|G or V into the bone defects. For information of handling and mixing please see the attached instructions for use (IFU). | Device | Treated with Device: Including sham |
Primary outcome
incidence of post-surgical infection
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
CARLO L ROMANO, MD principal investigator
IRCCS GALEAZZI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CERAMENT G V in people with Hip Prosthesis Infection and Knee Prosthesis Infection, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 6 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 3 Jan 2018. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CARLO L ROMANO, MD (+39026621441 ext. 907, carlo.romano@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of post-surgical infection (time frame: 12 months). 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 3 Jan 2018.