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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. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014