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.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 39
- 试验地点
- 28
- 主要终点
- Recurrence of clinically diagnosed infection relapse of the periprosthetic joint
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: Defensive Antiadhesive Coating DAC®, Novagenit SRL (Device)
control group : two-stage surgery
Control group is composed of two-stage procedure without biofilm inhibitor (standard protocol)
结局指标
主要结局
Recurrence of clinically diagnosed infection relapse of the periprosthetic joint
时间窗: 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.
次要结局
- Hip dysfunction and Osteoarthritis Outcome Score (HOOS) results(Years : 2)
- Revision surgery for any cause other than infection(Years : 2)
- Post-operative complications(Years : 2)
- Postel-Merle d'Aubigné (PMA) results(Years : 2)
- Harris Hip Score (HHS) results(Years : 2)
- Oxford-12 results(Years : 2)
- Death rate (%)(Years : 2)