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

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.

Study Overview

• Status: Unknown
• Conditions: Hip Prosthesis Infection; Knee Prosthesis Infection
• Intervention / Treatment: Device: CERAMENT G V

• Study Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Milano, Italy
    • Recruiting
    • IRCCS Galeazzi
    • Contact: CARLO L ROMANO, MD; Phone Number: 907 +39026621441; Email: carlo.romano@grupposandonato.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of post-surgical infection	12 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Galeazzi
• Investigators: Principal Investigator: CARLO L ROMANO, MD, IRCCS Galeazzi

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Anticipated): September 27, 2018
• Study Completion (Anticipated): September 27, 2019

Study Registration Dates

• First Submitted: December 26, 2017
• First Submitted That Met QC Criteria: December 26, 2017
• First Posted (Actual): January 3, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2018
• Last Update Submitted That Met QC Criteria: December 26, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: RAI2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No