Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
NCT ID: NCT03113981
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
340 participants
INTERVENTIONAL
2017-05-08
2039-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ACTISURF-CERAFIT
Total hip arthroplasty (CERAFIT) grafted by PolyNass
Total Hip Arthroplasty
Implanting THA grafted with PolyNass or not
CERAFIT
Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) not grafted by PolyNass
Total Hip Arthroplasty
Implanting THA grafted with PolyNass or not
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Total Hip Arthroplasty
Implanting THA grafted with PolyNass or not
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* THA following a primary or secondary osteoarthritis
* THA following an aseptic osteonecrosis
* THA following a rapidly destructive osteoarthritis
* Social insurance
* Informed and signed consent
Exclusion Criteria
* Inflammatory rheumatism
* Long-term corticosteroid treatment
* Tumor Pathology of the hip bone
* Study femoral stem not adapted to the patient's anatomy (verified on preoperative X-rays using Ceraver templates).
* Loss of bone of the joint that makes it impossible to properly anchor a cementless prosthesis
* Acetabular or femoral bone graft associated
* Infectious hip arthritis history
* Evolving infection of the articulation or peri-articular region involved, including severe neuroarthropathy
* Surgical history on the affected hip
* Allergy known to any component of prostheses
* Known hypersensitivity to polystyrene sulfonate resins
* Native cotyl with a diameter of less than 42mm or greater than 68mm
* Significant muscle loss, neuromuscular injury or vascular insufficiency of affected limb
* Charcot's disease
* Immunocompromised patients
* Difficulties of follow-up (departure on vacation, imminent change, geographical distance, patients not residing in metropolis, insufficient motivation) or understanding of the protocol
* Patient Refusal
* Pregnant and lactating women
18 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Slb Pharma
OTHER
Societe ACTIVBIOMAT
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Thomas Bauer, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Ambroise Paré Paris
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU de Bordeaux Site Pellegrin
Bordeaux, , France
Hopital Ambroise Pare
Boulogne-Billancourt, , France
CH Privé Brestois et Clinique Pasteur
Brest, , France
CHU Cavale Blanche
Brest, , France
Hôpital Lariboisière
Paris, , France
CH de Cornouaille
Quimper, , France
HUS
Strasbourg, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-A01919-40
Identifier Type: OTHER
Identifier Source: secondary_id
ACTISURF-OI-16
Identifier Type: -
Identifier Source: org_study_id