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

Hip Prosthesis Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03389646
• Other study ID #: RAI2017
• Status: Recruiting
• Phase: Phase 4
• First received: December 26, 2017
• Last updated: December 26, 2017
• Start date: September 27, 2017
• Est. completion date: September 27, 2019

Study information

• Verified date: December 2017
• Source: Istituto Ortopedico Galeazzi
• Contact: CARLO L ROMANO, MD
• Phone: +39026621441
• Email: carlo.romano[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: September 27, 2019
• Est. primary completion date: September 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hip Prosthesis Infection
• Infection
• Knee Prosthesis Infection

Intervention

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).

Locations

Country	Name	City	State
Italy	Irccs Galeazzi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of post-surgical infection		12 months