Active — Not RecruitingNot Applicable

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

France340 participantsStarted 2017-05-08

Plain-language 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 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

Who can participate

Age range18 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)…

What they're measuring

Osseous-integration of the femoral stem and the acetabular component

Timeframe: 1 year post-surgery for both groups

Trial details

NCT IDNCT03113981

SponsorSociete ACTIVBIOMAT

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-31