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

Study Overview
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Brief Summary
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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

Official Title
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Randomized Controlled Non-inferiority Trial Assessing the Osseointegration of THA Grafted by PolyNASS (ACTISURF-CERAFIT® ) Versus Non-grafted THA (CERAFIT®)

Conditions
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Osteoarthritis, Hip

Intervention / Treatment
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* Device: Total Hip Arthroplasty


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACTISURF-CERAFIT<br>Total hip arthroplasty (CERAFIT) grafted by PolyNass | Device: Total Hip Arthroplasty<br>* Implanting THA grafted with PolyNass or not<br>|
| Active Comparator: CERAFIT<br>Total hip arthroplasty (CERAFIT) with HydroxyApatite (HA) no grafted by PolyNass | Device: Total Hip Arthroplasty<br>* Implanting THA grafted with PolyNass or not<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection rate | yes/no | 2-year | 
| Score ARA femur of Epinette | Adaptation criteria of the bone to the cementless stem | 1-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 2-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 4-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 6-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 8-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 10-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 12-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 14-year | 
| Harris Hip Score (HHS) | 10 question items and scores range from 0-100 with higher scores representing less dysfunction and better outcomes. | 16-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 2-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 4-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 6-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 8-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 10-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 12-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 14-year | 
| Postel Merle d'Aubigné (PMA) score | From 18 (perfect) to 0 (worst) | 16-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 2-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 4-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 6-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 8-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 10-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 12-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 14-year | 
| Forgotten Hip Score (FHS) | 12 question items and scores range from 0-100 with higher scores representing a forgotten hip (excellent) | 16-year | 
| THA survival | Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure) | 6-year | 
| THA survival | Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure) | 10-year | 
| THA survival | Event=THA revision (change of the stem or acetabular component) whatever the reason (infectious or mechanical failure) | 16-year |