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New hip implant coating aims to cut infection risk and boost bone bonding

NCT ID NCT03113981

Disease control Sponsor: Societe ACTIVBIOMAT Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new coating on a hip replacement implant that may help prevent infections and help the implant bond better with the bone. About 340 adults needing a hip replacement will receive either the coated or standard implant. The goal is to see if the coated implant works as well or better than the standard one.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

340 people

The number who actually took part.

Started

May 2017

Expected to finish

Dec 2039

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged over 50 and under 75 years OR aged under 50 years with joint lesions not amenable to successful conservative treatment. * 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: * Patients younger than 50 years and with joint lesions that can be successfully treated with conservative treatment * 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

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Conditions

The condition(s) this trial relates to.

avascular necrosis of femoral head, primary, 1 idiopathic avascular necrosis infertility disorder Neoplasm Metastasis osteoarthritis, hip osteonecrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Coxarthrosis; primary Coxarthrosis; secondary Hip arthroplasty Hip arthroplasty replacement Hip arthroplasty, total Osteoarthritis, hip Osteonecrosis; aseptic, idiopathic

Contacts and locations

Locations

  • CH Privé Brestois et Clinique Pasteur

    Brest, 29200, France

  • CH de Cornouaille

    Quimper, 29107, France

  • CHU Cavale Blanche

    Brest, 29200, France

  • CHU de Bordeaux Site Pellegrin

    Bordeaux, 33076, France

  • HUS

    Strasbourg, 67200, France

  • Hopital Ambroise Pare

    Boulogne-Billancourt, 92000, France

  • Hôpital Lariboisière

    Paris, 75010, France

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