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

Primary Purpose

Hip Prosthesis Infection, Knee Prosthesis Infection

Status

Unknown status

Phase

Phase 4

Locations

Italy

Study Type

Interventional

Intervention

CERAMENT G V

About this trial

This is an interventional prevention trial for Hip Prosthesis Infection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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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Sites / Locations

Irccs GaleazziRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Treated with Device: Including sham

Control

Arm Description

Treated with CERAMENTTM|G or V for filling of bone defects in the tibia and/or femur and/or the acetabulum.

Control without CERAMENT device

Outcomes

Primary Outcome Measures

incidence of post-surgical infection

Secondary Outcome Measures

Full Information

NCT ID

NCT03389646

First Posted

December 26, 2017

Last Updated

December 26, 2017

Sponsor

Istituto Ortopedico Galeazzi

1. Study Identification

Unique Protocol Identification Number

NCT03389646

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

September 27, 2017 (Actual)

Primary Completion Date

September 27, 2018 (Anticipated)

Study Completion Date

September 27, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Istituto Ortopedico Galeazzi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hip Prosthesis Infection, Knee Prosthesis Infection

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Prospective with retrospective matched controls.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treated with Device: Including sham

Arm Type

Active Comparator

Arm Description

Treated with CERAMENTTM|G or V for filling of bone defects in the tibia and/or femur and/or the acetabulum.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control without CERAMENT device

Intervention Type

Device

Intervention Name(s)

CERAMENT G V

Intervention Description

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).

Primary Outcome Measure Information:

Title

incidence of post-surgical infection

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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. -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

CARLO L ROMANO, MD

Phone

+39026621441

Ext

907

carlo.romano@grupposandonato.it

First Name & Middle Initial & Last Name or Official Title & Degree

NICOLA LOGOLUSO, MD

Phone

+39026621441

Ext

903

nicola.logoluso@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

CARLO L ROMANO, MD

Organizational Affiliation

IRCCS GALEAZZI

Official's Role

Principal Investigator

Facility Information:

Facility Name

Irccs Galeazzi

City

Milano

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

CARLO L ROMANO, MD

Phone

+39026621441

Ext

907

carlo.romano@grupposandonato.it

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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