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

NCT ID: NCT01454271

Last Updated: 2018-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Arthroplasty Replacement

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Total Hip Arthroplasty CERAFIT® grafted

Group Type EXPERIMENTAL

Total Hip Arthroplasty Replacement

Intervention Type PROCEDURE

Total Hip Arthroplasty Replacement

Interventions

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Total Hip Arthroplasty Replacement

Total Hip Arthroplasty Replacement

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Societe ACTIVBIOMAT

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Philippe Hardy, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Ambroise Paré Hospital

Locations

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Ambroise Paré Hospital. Orthopaedic surgery department

Boulogne-Billancourt, Île-de-France Region, France

Site Status

Countries

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France

Other Identifiers

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2011-A00597-34

Identifier Type: OTHER

Identifier Source: secondary_id

CERAVERBIO11

Identifier Type: -

Identifier Source: org_study_id

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