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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

Tracking Information
First Submitted Date  ICMJE December 26, 2017
First Posted Date  ICMJE January 3, 2018
Last Update Posted Date January 3, 2018
Actual Study Start Date  ICMJE September 27, 2017
Estimated Primary Completion Date September 27, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 26, 2017)
incidence of post-surgical infection [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
Official Title  ICMJE CERAMENTTM|G and V in the Management of Hip and Knee Arthroplasty Revisions (Revision Arthroplasty Italy)
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective with retrospective matched controls.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hip Prosthesis Infection
  • Knee Prosthesis Infection
Intervention  ICMJE 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).
Study Arms  ICMJE
  • 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.
    Intervention: Device: CERAMENT G V
  • No Intervention: Control
    Control without CERAMENT device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 26, 2017)
135
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 27, 2019
Estimated Primary Completion Date September 27, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: CARLO L ROMANO, MD +39026621441 ext 907 carlo.romano@grupposandonato.it
Contact: NICOLA LOGOLUSO, MD +39026621441 ext 903 nicola.logoluso@gmail.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03389646
Other Study ID Numbers  ICMJE RAI2017
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Istituto Ortopedico Galeazzi
Study Sponsor  ICMJE Istituto Ortopedico Galeazzi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: CARLO L ROMANO, MD IRCCS GALEAZZI
PRS Account Istituto Ortopedico Galeazzi
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP