Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®
- Conditions
- Osteoarthritis, Hip
- Interventions
- Device: Total Hip Arthroplasty
- Registration Number
- NCT03113981
- Lead Sponsor
- Laboratoire Ceraver-Osteal
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 380
- THA following a primary or secondary osteoarthritis
- THA following an aseptic osteonecrosis
- Social insurance
- Informed and signed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ACTISURF-CERAFIT Total Hip Arthroplasty Total hip arthroplasty (CERAFIT) grafted by PolyNass CERAFIT Total Hip Arthroplasty Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) no grafted by PolyNass
- Primary Outcome Measures
Name Time Method Osseous-integration of the femoral stem and the acetabular component 1-year (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
- Secondary Outcome Measures
Name Time Method THA survival 16-year Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure)
Score ARA femur of Epinette 1-year Adaptation criteria of the bone to the cementless stem
Forgotten Hip Score (FHS) 16-year 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent)
Infection rate 2-year yes/no
Harris Hip Score (HHS) 16-year 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes.
Postel Merle d'Aubigné (PMA) score 16-year From 18 (perfect) to 0 (worst)
Trial Locations
- Locations (1)
Hopital Ambroise Pare
🇫🇷Boulogne-Billancourt, France