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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)

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ClinicalTrials.gov Identifier: NCT04251377
Recruitment Status : Not yet recruiting
First Posted : January 31, 2020
Last Update Posted : July 8, 2020
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date July 8, 2020
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
Recurrence of clinically diagnosed infection relapse of the periprosthetic joint [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Harris Hip Score (HHS) results [ Time Frame: 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.
  • Postel-Merle d'Aubigné (PMA) results [ Time Frame: 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.
  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS) results [ Time Frame: 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.
  • Oxford-12 results [ Time Frame: 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 (%) [ Time Frame: Years : 2 ]
    Analysis of death rate by group.
  • Post-operative complications [ Time Frame: Years : 2 ]
    Analysis of post-operative complications by group.
  • Revision surgery for any cause other than infection [ Time Frame: Years : 2 ]
    Analysis of revision surgery for any cause other than infection.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection
Official Title  ICMJE 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.
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hip Prosthesis Infection
Intervention  ICMJE Device: Defensive Antiadhesive Coating DAC®, Novagenit SRL

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.

Study Arms  ICMJE
  • Experimental: 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
    Intervention: Device: Defensive Antiadhesive Coating DAC®, Novagenit SRL
  • No Intervention: control group : two-stage surgery
    Control group is composed of two-stage procedure without biofilm inhibitor (standard protocol)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
440
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bertrand BOYER, MD (0)477120820 ext +33 bertrand.boyer@chu-st-etienne.fr
Contact: Carine LABRUYERE, CRA (0)477120469 ext +33 carine.labruyere@chu-st-etienne.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251377
Other Study ID Numbers  ICMJE 18PH222
ANSM ( Other Identifier: 2019-A01491-56 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Saint Etienne
Study Sponsor  ICMJE Centre Hospitalier Universitaire de Saint Etienne
Collaborators  ICMJE Ministry of Health, France
Investigators  ICMJE
Principal Investigator: Bertrand BOYER, MD CHU SAINT-ETIENNE
PRS Account Centre Hospitalier Universitaire de Saint Etienne
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP