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.

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
CHU Amiens
NOT_YET_RECRUITING
Amiens
CHU Bordeaux
NOT_YET_RECRUITING
Bordeaux
CHU Caen
NOT_YET_RECRUITING
Caen
CHU Clermont-Ferrand
NOT_YET_RECRUITING
Clermont-ferrand
CHU Dijon
NOT_YET_RECRUITING
Dijon
CHU Lille
NOT_YET_RECRUITING
Lille
HCL - Hôpital de la Croix Rousse
NOT_YET_RECRUITING
Lyon
HCL - Hôpital Edouard Herriot
NOT_YET_RECRUITING
Lyon
CHU Marseille
NOT_YET_RECRUITING
Marseille
CHU Nancy
NOT_YET_RECRUITING
Nancy
CHU Nantes
NOT_YET_RECRUITING
Nantes
CHU Nice
NOT_YET_RECRUITING
Nice
Chu Saint-Etienne
RECRUITING
Saint-etienne
CHU Toulouse
NOT_YET_RECRUITING
Toulouse
Contact Information
Primary
Bertrand BOYER, MD
bertrand.boyer@chu-st-etienne.fr
(0)477120820
Backup
Carine LABRUYERE, CRA
carine.labruyere@chu-st-etienne.fr
(0)477120469
Time Frame
Start Date: 2021-09-30
Estimated Completion Date: 2026-12
Participants
Target number of participants: 440
Treatments
Experimental: Single-stage surgery + DAC® + topical antibiotics
Experimental group is composed of single-stage procedure associated to the use of biofilm inhibitor (Defensive Antibacterial Coating® DAC®) and topical antibiotics=new strategy
No_intervention: control group : two-stage surgery
Control group is composed of two-stage procedure without biofilm inhibitor (standard protocol)
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire de Saint Etienne
Collaborators: Ministry of Health, France

This content was sourced from clinicaltrials.gov

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