Clinical trial NCT03113981: Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®
Official title: Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Osteoarthritis, Hip
Lead sponsor: Laboratoire Ceraver-Osteal
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The infection rate after Total Hip Arthroplasty (THA) is about 1%. It is a serious condition, with high morbidity, sometimes fatal, requiring costly treatment.

The treatment is difficult because "biofilm" forms very early after the bacterial contamination of the prosthesis.

Prevent infection means reduce or prevent the formation of bacterial biofilm and controlling protein response to allow osseous-integration of the prosthesis.

A new prosthesis was developped, grafted by PolyNaSS (polysodium styrenesulfonate). This bioactive polymer allows to substantially reduce bacterial adhesion, biocompatibility, bio-integration in preclinical studies. This first clinical study aims to compare the osseous-integration of this prosthesis to the same prothesis with no grafting.

No previous clinical trial


Eligibility criteria: Inclusion Criteria:

* THA following a primary or secondary osteoarthritis
* THA following an aseptic osteonecrosis
* Social insurance
* Informed and signed consent

Exclusion Criteria:

* Patients younger than 50 years and with joint lesions that can be successfully treated with conservative treatment
* Rheumatoid arthritis
* Steroid treatment on-going
* Tumor Pathology of the hip bone
* Loss of bone of the joint that makes it impossible to properly anchor a cementless prosthesis
* Acetabular or femoral bone graft associated
* Infectious hip arthritis history
* Evolving infection of the articulation or peri-articular region involved, including severe neuroarthropathy
* Surgical history on the affected hip
* Allergy known to any component of prostheses
* Known hypersensitivity to polystyrene sulfonate resins
* Native cotyl with a diameter of less than 42mm or greater than 68mm
* Significant muscle loss, neuromuscular injury or vascular insufficiency of affected limb
* Charcot's disease
* Immunocompromised patients
* Difficulties of follow-up (departure on vacation, imminent change, geographical distance, patients not residing in metropolis, insufficient motivation) or understanding of the protocol
* Patient Refusal
* Pregnant and lactating women

Primary outcomes:
measure: Osseous-integration of the femoral stem and the acetabular component
timeFrame: 1-year
Secondary outcomes:
measure: Infection rate
timeFrame: 2-year
measure: Score ARA femur of Epinette
timeFrame: 1-year
measure: Harris Hip Score (HHS)
timeFrame: 2-year
measure: Harris Hip Score (HHS)
timeFrame: 4-year
measure: Harris Hip Score (HHS)
timeFrame: 6-year
measure: Harris Hip Score (HHS)
timeFrame: 8-year
measure: Harris Hip Score (HHS)
timeFrame: 10-year
measure: Harris Hip Score (HHS)
timeFrame: 12-year
measure: Harris Hip Score (HHS)
timeFrame: 14-year
measure: Harris Hip Score (HHS)
timeFrame: 16-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 2-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 4-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 6-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 8-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 10-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 12-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 14-year
measure: Postel Merle d'Aubigné (PMA) score
timeFrame: 16-year
measure: Forgotten Hip Score (FHS)
timeFrame: 2-year
measure: Forgotten Hip Score (FHS)
timeFrame: 4-year
measure: Forgotten Hip Score (FHS)
timeFrame: 6-year
measure: Forgotten Hip Score (FHS)
timeFrame: 8-year
measure: Forgotten Hip Score (FHS)
timeFrame: 10-year
measure: Forgotten Hip Score (FHS)
timeFrame: 12-year
measure: Forgotten Hip Score (FHS)
timeFrame: 14-year
measure: Forgotten Hip Score (FHS)
timeFrame: 16-year
measure: THA survival
timeFrame: 6-year
measure: THA survival
timeFrame: 10-year
measure: THA survival
timeFrame: 16-year
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Hopital Ambroise Pare
Study officials:
affiliation: Hospital Ambroise Paré Paris
name: Thomas Bauer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: