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

NCT04251377 | Active Not Recruiting DMC

• 2 other identifiers: 18PH222ANSM
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 14

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.

Conditions

Hip Prosthesis Infection

Keywords

Surgery; Biofilm inhibitor; Chronic infections; Total Hip Arthroplasties (THA); Defensive Antibacterial Coating (DAC®); Novagenit®; Hip Prosthesis

Outcome Measures

Primary Outcomes (1)

• Recurrence of clinically diagnosed infection relapse of the periprosthetic joint

  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.

  Years : 2

Secondary Outcomes (7)

• Harris Hip Score (HHS) results

  Years : 2

• Postel-Merle d'Aubigné (PMA) results

  Years : 2

• Hip dysfunction and Osteoarthritis Outcome Score (HOOS) results

  Years : 2

• Oxford-12 results

  Years : 2

• Death rate (%)

  Years : 2

Study Arms (2)

Single-stage surgery + DAC® + topical antibiotics

EXPERIMENTAL

Experimental group is composed of single-stage procedure associated to the use of biofilm inhibitor (Defensive Antibacterial Coating® DAC®) and topical antibiotics=new strategy

Device: Defensive Antiadhesive Coating DAC®, Novagenit SRL

control group : two-stage surgery

NO INTERVENTION

Control group is composed of two-stage procedure without biofilm inhibitor (standard protocol)

Interventions

Defensive Antiadhesive Coating DAC®, Novagenit SRL DEVICE

DAC gel, mixed with topical antibiotics is applied on the surface of the implants before implantation, in a sterile environment in the operating room. The topical antibiotics will be added to the reconstituted DAC® gel preparation, at the discretion of the physician, on the basis of pre-operative culture.

Single-stage surgery + DAC® + topical antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with hypersensitivity to hydrogel components (hyaluronic acid and/or poly-lactic acid) known of Defensive Antibacterial Coating (DAC)®
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (14)

CHU Amiens

Amiens, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU Caen

Caen, France

Location

CHU Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Dijon

Dijon, France

Location

CHU Lille

Lille, France

Location

HCL - Hôpital de la Croix Rousse

Lyon, France

Location

HCL - Hôpital Edouard Herriot

Lyon, France

Location

CHU Marseille

Marseille, France

Location

CHU Nancy

Nancy, France

Location

CHU Nantes

Nantes, France

Location

CHU Nice

Nice, France

Location

Chu Saint-Etienne

Saint-Etienne, France

Location

CHU Toulouse

Toulouse, France

Location

Related Publications (1)

• Boyer B, Cazorla C, Carricajo A, Labruyere C, Chapelle C, Presles E, Zufferey P, Botelho-Nevers E. Single-stage surgery with antibiotic-loaded hydrogel-coated implants versus two-stage surgery for chronic periprosthetic hip joint infection in French tertiary referral hospitals: the SINBIOSE-H non-inferiority, randomised, controlled trial study protocol. BMJ Open. 2025 Feb 25;15(2):e085146. doi: 10.1136/bmjopen-2024-085146.

  PMID: 40000087 DERIVED

MeSH Terms

Conditions

Persistent Infection; Limb Deficiencies, Distal, with Micrognathia

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bertrand BOYER, MD

  Centre Hospitalier Universitaire de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: January 31, 2020
• Study Start: September 30, 2021
• Primary Completion: May 30, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (14)