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Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

NCT03113981 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2025-12-22

No results posted yet for this study

Summary

The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment.

The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis.

Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis.

A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion and increase biocompatibility and bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting.

No previous clinical trial

Conditions

  • Osteoarthritis, Hip
  • Coxarthrosis; Primary
  • Coxarthrosis; Secondary
  • Osteonecrosis; Aseptic, Idiopathic
  • Hip Arthroplasty Replacement
  • Hip Arthroplasty, Total
  • Hip Arthroplasty

Interventions

DEVICE

Total Hip Arthroplasty

Implanting THA grafted with PolyNass or not

Sponsors & Collaborators

  • Slb Pharma

    collaborator OTHER

  • Societe ACTIVBIOMAT

    lead INDUSTRY

Principal Investigators

  • Thomas Bauer, MD, PhD · Hospital Ambroise Paré Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2024-12-31
Completion
2039-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113981 on ClinicalTrials.gov