Hip Prosthesis Infection, Knee Prosthesis Infection
Conditions
Brief 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 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.
Interventions
DEVICECERAMENT G V
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).
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Prospective with retrospective matched controls.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Written informed consent obtained prior to any study related procedure. 2. Male or female age ≥ 18 and ≤ 85 years. 3. Patients diagnosed with aseptic prosthetic loosening and scheduled for a one-stage hip or knee cementless or hybrid revision prosthesis implantation 4. Patients with an interval spacer and scheduled for hip or knee cementless or hybrid revision prosthesis implantation. 5. For those patients with an interval spacer, previous infection caused by microorganism(s) sensitive to gentamicin or vancomycin. 6. Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion criteria
1. Unable to give written informed consent. 2. Medically unfit for operative intervention. 3. Soft-tissue defects that prevent direct skin closure at revision surgery. 4. Females who are pregnant or lactating. 5. 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. 6. Known allergy to gentamicin or vancomycin (or related antibiotics). 7. Patients with previous nephro- or ototoxicity events due to aminoglycoside and/or vancomycin (or glycopeptides) use. 8. Presence of relevant contraindications as described in the EU CE mark Instructions for Use (IFU). 9. Myasthenia gravis. 10. Need of a fully cemented joint prosthesis. 11. Psychiatric or neurological disorders. 12. Active infection at the site of surgery as diagnosed by clinical and/or laboratory and/or imaging investigations. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of post-surgical infection | 12 months |
Countries
Italy
Contacts
Primary ContactCARLO L ROMANO, MD
Backup ContactNICOLA LOGOLUSO, MD
Outcome results
None listed