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

N/AActive Not RecruitingNCT03113981

Societe ACTIVBIOMAT340 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

340

Conditions

Osteoarthritis, Hip Coxarthrosis; Primary Coxarthrosis; Secondary Osteonecrosis; Aseptic, Idiopathic

Eligibility

Sex: ALLMin age: 18 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (7)

CHU de Bordeaux Site Pellegrin

Bordeaux, France

Hopital Ambroise Pare

Boulogne-Billancourt, France

CH Privé Brestois et Clinique Pasteur

Brest, France

CHU Cavale Blanche

Brest, France

Hôpital Lariboisière

Paris, France

CH de Cornouaille

Quimper, France

HUS

Strasbourg, France

Outcomes

Primary Outcomes

Osseous-integration of the femoral stem and the acetabular component

(Yes/No). THA will be judged "osseointegrated" if the acetabulum AND the femur meet the following osseous-integration criteria: * femur: score of Engh and Massin strictly greater than 10 * AND acetabulum: Implant migration less than 5 mm AND no total radiolucent line and no osteocondensation at the bone-cup interface in the 3 zones of Gruen

Time frame: 1 year post-surgery for both groups

Secondary Outcomes

Mid-term survival rate of the hip prosthesis

Based on the unipolar or bipolar change of the femoral head regardless of the cause, septic or mechanical.

Time frame: 15 years post-surgery for CERAFIT group and 16 years post-surgery for ACTISURF group

Score ARA femur of Epinette

Adaptation criteria of the bone to the cementless stem

Time frame: 1 year post-surgery for both groups

Hip prosthesis infection rate defined according to the 2011 criteria of the Musculoskeletal Infection Society (MSIS). In case of suspicion of infection, a hip joint aspiration with synovial fluid culture will be performed.

yes/no

Time frame: 2 years post-surgery for both groups

Postel Merle d'Aubigné (PMA) score

From 18 (perfect) to 0 (worst)

Time frame: 2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.

Harris Hip Score (HHS)

10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.

Time frame: 2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.

Forgotten Hip Score (FHS)

12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)

Time frame: 2 years post-surgery for both groups. 5, 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.

Osseous-integration of the femoral stem and the acetabular component based on radiographies

Subsidence of the femoral stem, presence of periprosthetic radiolucent lines in the Gruen and Amstutz zones (femur) and in the DeLee and Charnley zones (acetabulum), Brooker score

Time frame: 2 years post-surgery for both groups. 5 and 10 years post-surgery for CERAFIT group. 4, 6, 8, 10, 12, 14, 16 years post-surgery for ACTISURF group.

THA survival

Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)

Time frame: 6 years post-surgery for ACTISURF group. 10 years post-surgery for both groups.

Adverse and serious adverse events evaluation

Occurrence of related to THA serious adverse events after 2 post-operative years

Time frame: For ACTISURF group: at 4, 6, 8, 10, 12, 14, 16 years post-surgery. For CERAFIT group: at 5, 10, and 15 years post-surgery.

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

Overview

Conditions

Interventions

Eligibility

Locations (7)

Outcomes

Primary Outcomes

Secondary Outcomes