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Clinical Trial NCT04251377 (SINBIOSE-H) for Hip Prosthesis Infection is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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)
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.
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
- 18PH222
- ANSM (Other Identifier) (2019-A01491-56)
Biofilm inhibitor
Chronic infections
Total Hip Arthroplasties (THA)
Defensive Antibacterial Coating (DAC®)
Novagenit®
Hip Prosthesis
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSingle-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 | 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. |
No Interventioncontrol group : two-stage surgery Control group is composed of two-stage procedure without biofilm inhibitor (standard protocol) | N/A |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
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 |
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 |
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 |
Death rate (%) | Analysis of death rate by group. | Years : 2 |
Post-operative complications | Analysis of post-operative complications by group. | Years : 2 |
Revision surgery for any cause other than infection | Analysis of revision surgery for any cause other than infection. | Years : 2 |
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
Centre Hospitalier Universitaire de Saint EtienneMinistry of Health, France