NCT01454271

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2011

Completed
Last Updated

August 14, 2018

Status Verified

August 1, 2018

First QC Date

October 14, 2011

Last Update Submit

August 12, 2018

Conditions

Hip Arthroplasty Replacement

Keywords

Total Hip arthroplastyHip OsteoarthritisInfection after Total Hip Arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Femoral component osseous-integration

    Scoring system of Engh

    1 year after surgery

Secondary Outcomes (2)

  • Infection rate

    1 year after surgery

  • Quality of Life

    One, three, six and twelve months after surgery

Study Arms (1)

Total Hip Arthroplasty CERAFIT® grafted

EXPERIMENTAL
Procedure: Total Hip Arthroplasty Replacement

Interventions

Total Hip Arthroplasty ReplacementPROCEDURE

Total Hip Arthroplasty Replacement

Total Hip Arthroplasty CERAFIT® grafted

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous infectious hip arthritis
  • Previous surgeries on the operated hip
  • Revision of THA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambroise Paré Hospital. Orthopaedic surgery department

Boulogne-Billancourt, Île-de-France Region, 92100, France

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Arthroplasty, Replacement, Hip

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty, ReplacementArthroplastyOrthopedic ProceduresSurgical Procedures, OperativePlastic Surgery ProceduresProsthesis Implantation

Study Officials

  • Philippe Hardy, Ph.D.

    Ambroise Paré Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2011

First Posted

October 18, 2011

Last Updated

August 14, 2018

Record last verified: 2018-08

Locations

FR(1)