Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate

This study is not yet open for participant recruitment.
Verified November 2013 by Laboratoire Ceraver-Osteal
Sponsor:
Information provided by (Responsible Party):
Laboratoire Ceraver-Osteal
ClinicalTrials.gov Identifier:
NCT01454271
First received: October 14, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

The risk of infection after primary Total Hip Arthroplasties (THA)is generally estimated to be less than 1% but remains a severe and costly complication, source of morbidity and even mortality. The "biofilm" forms very early after the bacterial contamination of the prosthesis and poses a number of clinical challenges due to his resistance to immune defence mechanisms and antibiotics. Preventive strategies are needed. The poly sodium styrene sulfonate (pNaSS) is a bioactive polymer. In vitro and in vivo studies showed that poly sodium styrene sulfonate grafted on titane surfaces reduce significantly the bacterial adhesion. They also proved his biocompatibility and osseous-integration.


Condition Intervention Phase
Hip Arthroplasty Replacement
Procedure: Total Hip Arthroplasty Replacement
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate

Further study details as provided by Laboratoire Ceraver-Osteal:

Primary Outcome Measures:
  • Femoral component osseous-integration [ Time Frame: 1 year after surgery ] [ Designated as safety issue: Yes ]
    Scoring system of Engh


Secondary Outcome Measures:
  • Infection rate [ Time Frame: 1 year after surgery ] [ Designated as safety issue: No ]

    Infection (yes/no) :

    Clinical, biological or radiological THA infection signs. In the case of infection suspicion, hip aspiration will be performed with joint fluid culture


  • Quality of Life [ Time Frame: One, three, six and twelve months after surgery ] [ Designated as safety issue: No ]
    SF-36 score


Estimated Enrollment: 50
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total Hip Arthroplasty CERAFIT® grafted Procedure: Total Hip Arthroplasty Replacement
Total Hip Arthroplasty Replacement

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age less than 75 years old
  • Aetiologies for THA : primary osteoarthritis, inflammatory diseases,Osteonecrosis

Exclusion Criteria:

  • Previous infectious hip arthritis
  • Previous surgeries on the operated hip
  • Revision of THA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454271

Contacts
Contact: Shahnaz Klouche, MD +33 (0) 6 28 35 04 78 klouche_shahnaz@yahoo.fr

Locations
France
Ambroise Paré Hospital. Orthopaedic surgery department Not yet recruiting
Boulogne-Billancourt, Ile de France, France, 92100
Principal Investigator: Philippe Hardy, Ph.D         
Sub-Investigator: Thomas Bauer, MD         
Sub-Investigator: Benoit Rousselin, MD         
Sponsors and Collaborators
Laboratoire Ceraver-Osteal
Investigators
Principal Investigator: Philippe Hardy, Ph.D. Ambroise Paré Hospital
  More Information

No publications provided

Responsible Party: Laboratoire Ceraver-Osteal
ClinicalTrials.gov Identifier: NCT01454271     History of Changes
Other Study ID Numbers: CERAVERBIO11, 2011-A00597-34
Study First Received: October 14, 2011
Last Updated: November 14, 2013
Health Authority: France: French Agency of Sanitary Safety of the Products of Health

Keywords provided by Laboratoire Ceraver-Osteal:
Total Hip arthroplasty
Hip Osteoarthritis
Infection after Total Hip Arthroplasty

ClinicalTrials.gov processed this record on April 17, 2014