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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2019-A01491-56 |
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-stage surgery + DAC® + topical antibiotics | Experimental | Experimental group is composed of single-stage procedure associated to the use of biofilm inhibitor (Defensive Antibacterial Coating® DAC®) and topical antibiotics=new strategy |
|
| control group : two-stage surgery | No Intervention | Control group is composed of two-stage procedure without biofilm inhibitor (standard protocol) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defensive Antiadhesive Coating DAC®, Novagenit SRL | Device | 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. |
| 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:
| Years : 2 |
| 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bertrand BOYER, MD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens | Amiens | France | ||||
| CHU Bordeaux |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40000087 | Derived | Boyer B, Cazorla C, Carricajo A, Labruyere C, Chapelle C, Presles E, Zufferey P, Botelho-Nevers E. Single-stage surgery with antibiotic-loaded hydrogel-coated implants versus two-stage surgery for chronic periprosthetic hip joint infection in French tertiary referral hospitals: the SINBIOSE-H non-inferiority, randomised, controlled trial study protocol. BMJ Open. 2025 Feb 25;15(2):e085146. doi: 10.1136/bmjopen-2024-085146. |
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|
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 |
| 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 | France |
| ID | Term |
|---|---|
| D000088562 | Persistent Infection |
| C565437 | Limb Deficiencies, Distal, with Micrognathia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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