Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection

Not Applicable

Recruiting

• Conditions: Hip Prosthesis Infection

• Registration Number: NCT04251377
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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

Study Timeline

• Study First Submitted: 2020-01-30
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-01-31
• Study Start: 2021-09-30
• Status Verified: 2025-04
• Primary Completion: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

CHU Amiens; 🇫🇷 Amiens, France

CHU Bordeaux; 🇫🇷 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

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