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

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ClinicalTrials.gov Identifier: NCT03389646
Recruitment Status : Recruiting
First Posted : January 3, 2018
Last Update Posted : January 3, 2018
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hip Prosthesis Infection Knee Prosthesis Infection Device: CERAMENT G V Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective with retrospective matched controls.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
Actual Study Start Date : September 27, 2017
Estimated Primary Completion Date : September 27, 2018
Estimated Study Completion Date : September 27, 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Treated with Device: Including sham
Treated with CERAMENTTM|G or V for filling of bone defects in the tibia and/or femur and/or the acetabulum.
 Device: CERAMENT 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).
No Intervention: Control
Control without CERAMENT device


Outcome Measures
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Primary Outcome Measures :
  1. incidence of post-surgical infection [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03389646


Contacts
Contact: CARLO L ROMANO, MD +39026621441 ext 907 carlo.romano@grupposandonato.it
Contact: NICOLA LOGOLUSO, MD +39026621441 ext 903 nicola.logoluso@gmail.com

Locations
Italy
Irccs Galeazzi Recruiting
Milano, Italy
Contact: CARLO L ROMANO, MD    +39026621441 ext 907    carlo.romano@grupposandonato.it   
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
Investigators
Principal Investigator: CARLO L ROMANO, MD IRCCS GALEAZZI
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03389646     History of Changes
Other Study ID Numbers: RAI2017
First Posted: January 3, 2018    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases