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

Hip Prosthesis Infection Clinical Trial

— SINBIOSE-H  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04251377
• Other study ID #: 18PH222
• Secondary ID: ANSM
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Bertrand BOYER, MD
• Phone: (0)477120820
• Email: bertrand.boyer[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Hip Prosthesis Infection
• Infections

Intervention

Device:
• Defensive Antiadhesive Coating DAC®, Novagenit SRL
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.

Locations

Country	Name	City	State
France	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	HCL - Hôpital de la Croix Rousse	Lyon
France	HCL - Hôpital Edouard Herriot	Lyon
France	CHU Marseille	Marseille
France	CHU Nancy	Nancy
France	CHU Nantes	Nantes
France	CHU Nice	Nice
France	Chu Saint-Etienne	Saint-etienne
France	CHU Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Years : 2
Secondary	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.	Years : 2
Secondary	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.	Years : 2
Secondary	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.	Years : 2
Secondary	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).	Years : 2
Secondary	Death rate (%)	Analysis of death rate by group.	Years : 2
Secondary	Post-operative complications	Analysis of post-operative complications by group.	Years : 2
Secondary	Revision surgery for any cause other than infection	Analysis of revision surgery for any cause other than infection.	Years : 2