Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection
- Conditions
- Hip Prosthesis Infection
- Interventions
- Device: Defensive Antiadhesive Coating DAC®, Novagenit SRL
- Registration Number
- NCT04251377
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 440
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Single-stage surgery + DAC® + topical antibiotics Defensive Antiadhesive Coating DAC®, Novagenit SRL Experimental group is composed of single-stage procedure associated to the use of biofilm inhibitor (Defensive Antibacterial Coating® DAC®) and topical antibiotics=new strategy
- Primary Outcome Measures
Name Time Method Recurrence of clinically diagnosed infection relapse of the periprosthetic joint Years : 2 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.
- Secondary Outcome Measures
Name Time Method Hip dysfunction and Osteoarthritis Outcome Score (HOOS) results Years : 2 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.
Revision surgery for any cause other than infection Years : 2 Analysis of revision surgery for any cause other than infection.
Post-operative complications Years : 2 Analysis of post-operative complications by group.
Postel-Merle d'Aubigné (PMA) results Years : 2 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.
Harris Hip Score (HHS) results Years : 2 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.
Oxford-12 results Years : 2 Oxford-12 allows to know the feelings of the patient during the last 4 weeks felt from 1 to 5 (satisfaction score).
Death rate (%) Years : 2 Analysis of death rate by group.
Trial Locations
- Locations (14)
HCL - Hôpital de la Croix Rousse
🇫🇷Lyon, France
CHU Marseille
🇫🇷Marseille, France
CHU Caen
🇫🇷Caen, France
CHU Amiens
🇫🇷Amiens, France
CHU Nice
🇫🇷Nice, France
CHU Lille
🇫🇷Lille, France
Chu Saint-Etienne
🇫🇷Saint-etienne, France
HCL - Hôpital Edouard Herriot
🇫🇷Lyon, France
CHU Bordeaux
🇫🇷Bordeaux, France
CHU Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CHU Dijon
🇫🇷Dijon, France
CHU Nantes
🇫🇷Nantes, France
CHU Nancy
🇫🇷Nancy, France
CHU Toulouse
🇫🇷Toulouse, France