Single-stage surgery with antibiotic-coated implants for hip joint infection prevention
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.
This study is testing whether a single surgery using special antibiotic-coated implants can help people with hip joint infections recover faster and avoid complications compared to the usual two-surgery method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 440 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 14 sites (Amiens and 13 other locations) |
| Trial ID | NCT04251377 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares a single-stage surgical approach using antibiotic-loaded hydrogel coated implants to the traditional two-stage surgery for patients with chronic periprosthetic hip joint infections. The single-stage method aims to reduce the time to rehabilitation and minimize complications associated with prolonged antibiotic treatment and multiple surgeries. Patients will undergo implant removal followed by immediate re-implantation of a new prosthesis during the same procedure. The study seeks to evaluate the effectiveness and safety of this innovative approach in preventing infection recurrence.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic periprosthetic hip joint infections who meet specific diagnostic criteria.
Not a fit: Patients with hypersensitivity to hydrogel components or those with a life expectancy significantly limited by other health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce recovery time and complications for patients suffering from hip prosthesis infections.
How similar studies have performed: While the two-stage surgery is a well-established protocol, the single-stage approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Amiens and 13 other locations
- CHU Amiens — Amiens, France (Not_yet_recruiting)
- CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
- CHU Caen — Caen, France (Not_yet_recruiting)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Not_yet_recruiting)
- CHU Dijon — Dijon, France (Not_yet_recruiting)
- CHU Lille — Lille, France (Not_yet_recruiting)
- HCL - Hôpital de la Croix Rousse — Lyon, France (Not_yet_recruiting)
- HCL - Hôpital Edouard Herriot — Lyon, France (Not_yet_recruiting)
- CHU Marseille — Marseille, France (Not_yet_recruiting)
- CHU Nancy — Nancy, France (Not_yet_recruiting)
- CHU Nantes — Nantes, France (Not_yet_recruiting)
- CHU Nice — Nice, France (Not_yet_recruiting)
- Chu Saint-Etienne — Saint-etienne, France (Recruiting)
- CHU Toulouse — Toulouse, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Bertrand BOYER, MD — Chu Saint-Etienne
- Study coordinator: Bertrand BOYER, MD
- Email: bertrand.boyer@chu-st-etienne.fr
- Phone: (0)477120820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.