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

L

Laboratoire Ceraver-Osteal

Status and phase

Withdrawn
Phase 2
Phase 1

Conditions

Hip Arthroplasty Replacement

Treatments

Procedure: Total Hip Arthroplasty Replacement

Study type

Interventional

Funder types

Industry

Identifiers

NCT01454271
CERAVERBIO11
2011-A00597-34 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

0 participants in 1 patient group

Total Hip Arthroplasty CERAFIT® grafted
Experimental group
Treatment:
Procedure: Total Hip Arthroplasty Replacement

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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