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One surgery instead of two? new coating may fight hip implant infections

NCT ID NCT04251377

Disease control Sponsor: Centre Hospitalier Universitaire de Saint Etienne 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a single-stage surgery using implants coated with an antibiotic-loaded hydrogel to the standard two-stage surgery for treating chronic hip prosthesis infections. The single-stage approach aims to remove the infected implant and place a new one in the same operation, potentially reducing hospital stays and complications. The trial includes 39 adults with confirmed hip implant infections and will track infection recurrence and hip function over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antibiotic-loaded hydrogel coating (DAC® gel) applied to hip implants
What this could lead to
If successful, this single-stage approach could become a simpler, faster treatment for hip implant infections, reducing the need for a second surgery and lengthy recovery.
What could go wrong
This is a small, early-phase trial with only 39 participants, so results may not apply broadly. The single-stage surgery may still fail to control infection as effectively as the standard two-stage approach.

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

39 people

The number who actually took part.

Started

Sep 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 years and older

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: * Social security affiliation * Signed informed consent * Chronic periprosthetic hip joint infection defined according to the Musculoskeletal Infection Society criteria : * Two positive periprosthetic cultures with phenotypically identical organisms * or a sinus tract communicating with the joint, * or having 3 of 5 minor criteria: * Elevated serum C-reactive protein (CRP) and Erythrocyte Sedimentation Rate (ESR); * Elevated synovial fluid White Blood Cell (WBC) count or change of ++ on leukocyte esterase test strip; * Elevated synovial fluid Polymorphonuclear Neutrophil Percentage (PMN%); * Positive histological analysis of periprosthetic tissue; * A single positive culture. Exclusion Criteria: * Patients with hypersensitivity to hydrogel components (hyaluronic acid and/or poly-lactic acid) known of Defensive Antibacterial Coating (DAC)® * Pregnancy or positive pregnancy test (performed in women of childbearing age before inclusion) * Life expectancy \< 3 months * Expected use of a cemented implant by the surgical team (for the treatment surgical protocol) * Unable to give informed consent * Patients under guardianship or curators * Refusal to participate

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Conditions

The condition(s) this trial relates to.

periprosthetic joint infection Persistent Infection prosthesis-related infectious disease split hand-foot malformation 3

As listed by the trial registrant

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

Hip prosthesis infection

Contacts and locations

Locations

  • CHU Amiens

    Amiens, France

  • CHU Bordeaux

    Bordeaux, France

  • CHU Caen

    Caen, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, France

  • CHU Dijon

    Dijon, France

  • CHU Lille

    Lille, France

  • CHU Marseille

    Marseille, France

  • CHU Nancy

    Nancy, France

  • CHU Nantes

    Nantes, France

  • CHU Nice

    Nice, France

  • CHU Toulouse

    Toulouse, France

  • Chu Saint-Etienne

    Saint-Etienne, France

  • HCL - Hôpital Edouard Herriot

    Lyon, France

  • HCL - Hôpital de la Croix Rousse

    Lyon, France

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