Informations générales (source: ClinicalTrials.gov)

NCT04251377 En recrutement
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. (SINBIOSE-H)
Interventional
  • Maladies transmissibles
  • Infection
N/A
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
septembre 2021
décembre 2026
09 avril 2025
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.
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Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Caen - Caen - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Clermont-Ferrand - Clermont-Ferrand - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Dijon - Dijon - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Lille - Lille - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Nancy - Nancy - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Toulouse - Toulouse - France Recrutement non commencé Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHU Amiens - Amiens - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Bordeaux - Bordeaux - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Marseille - Marseille - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Nantes - Nantes - France Recrutement non commencé Contact (sur clinicalTrials)
CHU Nice - Nice - France Recrutement non commencé Contact (sur clinicalTrials)
Chu Saint-Etienne - Saint-etienne - France En recrutement Contact (sur clinicalTrials)
HCL - Hôpital de la Croix Rousse - Lyon - France Recrutement non commencé Contact (sur clinicalTrials)
HCL - Hôpital Edouard Herriot - Lyon - France Recrutement non commencé Contact (sur clinicalTrials)

Critères

Tous
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.


- 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