Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

Societe ACTIVBIOMAT

Status: Active, not recruiting

Conditions: Hip Arthroplasty, Total; Hip Arthroplasty Replacement; Osteonecrosis; Aseptic, Idiopathic; Osteoarthritis, Hip; Coxarthrosis; Secondary; Coxarthrosis; Primary; Hip Arthroplasty

Treatments: Device: Total Hip Arthroplasty

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03113981

2015-A01919-40 (Other Identifier)

ACTISURF-OI-16

Details and patient eligibility

About

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 and increase biocompatibility and 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

Enrollment: 340 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged over 50 and under 75 years OR aged under 50 years with joint lesions not amenable to successful conservative treatment.
• THA following a primary or secondary osteoarthritis
• THA following an aseptic osteonecrosis
• THA following a rapidly destructive osteoarthritis
• 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
• Inflammatory rheumatism
• Long-term corticosteroid treatment
• Tumor Pathology of the hip bone
• Study femoral stem not adapted to the patient's anatomy (verified on preoperative X-rays using Ceraver templates).
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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340 participants in 2 patient groups

ACTISURF-CERAFIT

Experimental group

Description:

Total hip arthroplasty (CERAFIT) grafted by PolyNass

Treatment:

Device: Total Hip Arthroplasty

CERAFIT

Active Comparator group

Description:

Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) not grafted by PolyNass

Treatment:

Device: Total Hip Arthroplasty