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Hip Prosthesis InfectionSINBIOSE-HNCT04251377

Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection

A study testing Defensive Antiadhesive Coating DAC®, Novagenit SRL in people with Hip Prosthesis Infection, run by Centre Hospitalier Universitaire de Saint Etienne at 14 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Each year, around 1500 infected Total Hip Arthroplasties (THA) need non-conservative surgery, remaining an issue for patients and healthcare units. The recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Prosthesis Infection
What is being tested?
Defensive Antiadhesive Coating DAC®, Novagenit SRL
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
14 sitesFrance
Study dates
30 Sep 2021to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

France14 sites

  • CHU Amiens

    Amiens

  • CHU Bordeaux

    Bordeaux

  • CHU Caen

    Caen

  • CHU Clermont-Ferrand

    Clermont-Ferrand

  • CHU Dijon

    Dijon

  • CHU Lille

    Lille

  • HCL - Hôpital de la Croix Rousse

    Lyon

  • HCL - Hôpital Edouard Herriot

    Lyon

  • CHU Marseille

    Marseille

  • CHU Nancy

    Nancy

  • CHU Nantes

    Nantes

  • CHU Nice

    Nice

  • Chu Saint-Etienne

    Saint-Etienne

  • CHU Toulouse

    Toulouse

Other trials in France

About this study

Official title: Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection SINBIOSE-H.

Each year, around 1500 infected Total Hip Arthroplasties (THA) need non-conservative surgery, remaining an issue for patients and healthcare units. The recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. This protocol implies a first surgery to remove all infected implants and at least 6 weeks of antibiotic treatment without implant, then usually an antibiotic-free period and only then a second surgery to put back new implants and start the rehabilitation protocol, with usually more than a week of a second hospital stay. Between both surgeries, full-weight bearing is prohibited and joint stiffness and/or pain are rather usual complications. Failure rate is estimated at 10% in this two-stage strategy. The single-stage procedure (i.e. implanting back a new prosthesis during the same surgery after implant removal, synovectomy and lavage) is thought to be less susceptible to late functional complications (i.e. pain, stiffness and muscle deficiency) with a shorter, single hospital stay.

Although, with single-stage surgery, infection control could be less efficient because most pathogens produce during the first hours of infection an antibiotic-resistant layer called biofilm, allowing them to colonize and adhere to foreign objects like implants. This single-surgery protocol thus highly relies on antibiotics and has a list of contra-indications (based on experts' consensus): the presence of damaged soft tissues or a sinus tract, unknown pathogens, difficult to treat micro-organisms, severe immunosuppression and for many surgeons, each time a bone graft is necessary. Most of these contra-indications are directly related to the biofilm.

Read more

As no randomized control trial has ever compared single-stage versus two-stage surgery, the level of evidence for recommending one procedure over the other is low.

We conducted a survey that showed that most of the French reference centers have already switched to single stage surgery for single-stage non contra-indicated cases.

An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating®, Novagenit SRL), has been proven to mechanically prevent the biofilm formation, while allowing a prolonged intraarticular antibiotic release, in a randomized controlled trial in primary prevention of infection in THA.

The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for secondary prevention of peri-prosthetic hip joint infection. Moreover, using this device to prevent biofilm formation could expand one stage surgery to patients that are "normally" contra-indicated to one stage surgery.

Being tested
Defensive Antiadhesive Coating DAC®, Novagenit SRL
Keywords
Surgery, Biofilm inhibitor, Chronic infections, Total Hip Arthroplasties (THA), Defensive Antibacterial Coating (DAC®), Novagenit®, Hip Prosthesis
Medical subject headings
Persistent Infection, Limb Deficiencies, Distal, with Micrognathia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Defensive Antiadhesive Coating DAC®, Novagenit SRLDevice

    DAC gel, mixed with topical antibiotics is applied on the surface of the implants before implantation, in a sterile environment in the operating room.

    The topical antibiotics will be added to the reconstituted DAC® gel preparation, at the discretion of the physician, on the basis of pre-operative culture.

Study groups in NCT04251377
Study groupRoleWhat they receive
Single-stage surgery + DAC® + topical antibioticsExperimentalExperimental group is composed of single-stage procedure associated to the use of biofilm inhibitor (Defensive Antibacterial Coating® DAC®) and topical antibiotics=new strategy
Receives: Device: Defensive Antiadhesive Coating DAC®, Novagenit SRL
control group : two-stage surgeryNo interventionControl group is composed of two-stage procedure without biofilm inhibitor (standard protocol)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrence of clinically diagnosed infection relapse of the periprosthetic joint

    The periprosthetic joint infection is 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;
    • Elevated synovial fluid polymorphonuclear neutrophil percentage (PMN%);
    • Positive histological analysis of periprosthetic tissue;
    • A single positive culture.

    Measured: Years : 2

Secondary outcomes (7)

  1. Harris Hip Score (HHS) results

    Harris Hip Score (HHS) contains 10 items with maximum score at 100 for a perfect hip and minimum score at 0 for a very bad result.

    Measured: Years : 2

  2. Postel-Merle d'Aubigné (PMA) results

    Postel-Merle d'Aubigné (PMA) contains 3 items (pain, mobility and functional hip) with maximum score at 18 for a perfect hip and minimum score at 0 for a very bad result.

    Measured: Years : 2

  3. Hip dysfunction and Osteoarthritis Outcome Score (HOOS) results

    Hip dysfunction and Osteoarthritis Outcome Score contains 6 items (symptoms, stiffness, pain, function and daily life, sport and leisure activities, quality of life) and measure everyday activities with score from 0 to 4.

    Measured: Years : 2

  4. Oxford-12 results

    Oxford-12 allows to know the feelings of the patient during the last 4 weeks felt from 1 to 5 (satisfaction score).

    Measured: Years : 2

  5. Death rate (%)

    Analysis of death rate by group.

    Measured: Years : 2

  6. Post-operative complications

    Analysis of post-operative complications by group.

    Measured: Years : 2

  7. Revision surgery for any cause other than infection

    Analysis of revision surgery for any cause other than infection.

    Measured: Years : 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2020
  2. Study start30 Sep 2021
  3. Primary completion30 May 2024
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04251377
Sponsor's protocol ID
18PH222
Other IDs
ANSM
Acronym
SINBIOSE-H
Status last verified
May 2026
First submitted
30 Jan 2020
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Boyer B, Cazorla C, Carricajo A, Labruyere C, Chapelle C, Presles E, Zufferey P, Botelho-Nevers E. Single-stage surgery with antibiotic-loaded hydrogel-coated implants versus two-stage surgery for chronic periprosthetic hip joint infection in French tertiary referral hospitals: the SINBIOSE-H non-inferiority, randomised, controlled trial study protocol. BMJ Open. 2025 Feb 25;15(2):e085146. doi: 10.1136/bmjopen-2024-085146.

    PubMed 40000087

Questions about this trial

What is this clinical trial studying?

A study testing Defensive Antiadhesive Coating DAC®, Novagenit SRL in people with Hip Prosthesis Infection, run by Centre Hospitalier Universitaire de Saint Etienne at 14 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrence of clinically diagnosed infection relapse of the periprosthetic joint (time frame: Years : 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04251377, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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