Ignite Creation Date:
2024-05-06 @ 2:14 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04251377
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2020-01-30
Brief Title:
Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint Infection
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
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 andor pain are rather usual complications Failure rate is estimated at 10 in this two-stage strategy The single-stage procedure ie 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 ie 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ANSM | OTHER | 2019-A01491-56 | None |