Status:
UNKNOWN
CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
Lead Sponsor:
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Conditions:
Hip Prosthesis Infection
Knee Prosthesis Infection
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 de...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
- 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.
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Key Trial Info
Start Date :
September 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 27 2019
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03389646
Start Date
September 27 2017
End Date
September 27 2019
Last Update
January 3 2018
Active Locations (1)
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1
Irccs Galeazzi
Milan, Italy