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

  • STATUS
    Recruiting
  • End date
    Dec 24, 2024
  • participants needed
    440
  • sponsor
    Centre Hospitalier Universitaire de Saint Etienne
Updated on 24 November 2021

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. 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.

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.

Details
Condition Hip Prosthesis Infection
Treatment Defensive Antiadhesive Coating DAC®, Novagenit SRL
Clinical Study IdentifierNCT04251377
SponsorCentre Hospitalier Universitaire de Saint Etienne
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

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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