Single-stage surgery with antibiotic-coated implants for hip joint infection prevention

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chu Saint-Etienne
  Saint-etienne, France Recruiting
• 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

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluation of 3D Digital Surgery in Traumatology

  This study is testing if using 3D digital surgery tools can help patients with orthopedic conditions have better surgery outcomes and fewer complications compared to traditional methods.

  Recruiting Corporacion Parc Tauli · Sabadell, Barcelona · NCT06603831

• Custom-made implants for failed hip surgeries

  This study is testing whether custom-made hip implants can help adults who need surgery to fix problems from previous hip surgeries due to severe bone damage.

  Recruiting Istituto Ortopedico Rizzoli · Bologna · NCT06527664

• Long-term follow-up for hip prosthetic joint infections at University Hospitals Leuven

  This study looks at patients with hip joint infections after surgery to see how well different treatments work over time.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT05000723

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.