CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)

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.
• •\-