Multicentric, Open Label With Retrospective Inclusion and Follow-up of Acetabular Prothetic Implant Polymax

Study Overview
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Brief Summary
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Total replacement of hip joint is one of the most important medical innovations of the twentieth century. More than 100,000 hip replacements are being laid each year in France. Improved fixation, reduced wear rates and reduced implant dislocation rates remain subjects of continuous improvement. Hip implants cemented and cementless are part of therapeutic arsenal of orthopedic surgeons for joint replacement of the defective hip. The anchor and friction torque are both essential to the survival of hip implants. Therefore acetabular implants without cement with ceramic insert or polyethylene in a metalback or full polyethylene coated with titanium grains without metalback are proposed, but they have their own complications (Squeaking, fractures, recovery difficulties, difficult radiographic analysis, high cost for ceramics, primary stability defects, instability of the instrument set, Titanium residues in absence of metalback. An alternative to these implants may be an acetabular component without cement with polyethylene insert with an end metalback to increase both polyethylene thickness and size of the head in order to expect a low complication rate with important longevity for a lower cost. This study was conducted to ensure the safety and effectiveness of the acetabular implant POLYMAX

Official Title
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Multicentric, Open Label With Retrospective Inclusion and 5 Years Prospective Follow-up of Acetabular Prothetic Implant Polymax

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: Early complications data
* Other: Late stage complications data
* Other: Patient Satisfaction
* Other: Efficacity
* Other: Radiographic evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient suffering from hip disease: primary or secondary hip osteoarthritis or osteonecrosis. Patient having been implanted with a POLYMAX implant; Patient having agreed to participate in a follow-up 5 years; Patient who have accepted the use of their data in the context of this study. Patient having pre-operative and post-operative data Exclusion Criteria: Pre or post-operative Partial data Patients not available for follow up at 2 and 5 years .. Metabolic disease or autoimmune witch may interfere with bone growth not allowing the indication of a prosthesis without cement, Mental disorder or disease of proven behavior. Severe osteoporosis, Direct or indirect bone irradiation

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with acetabular implant<br>Data to be collected are : Early complications data related to implant or procedure of implantation Late stage complications data Efficacity of treatment with HIP score Patient satisfaction Radiographic evaluation during standard follow-up | Other: Early complications data<br>* Early complications of interest are : New arthroplasty for any reason Related to the implant : Wrong position of the implant Early displacement of the implant Related to the intervention : Hematoma Dislocation (or not causing the resumption of joint replacement) Deep vein thrombosis Pulmonary embolism Acute Infection<br>Other: Late stage complications data<br>* Late complications taken into account are: New arthroplasty for any reason Aseptic loosening Delayed hypersensitivity reaction type IV Solid Tumors Recurrent dislocation (causing or not the resumption of joint replacement) Allergic reactions of any kind Chronic infection<br>Other: Patient Satisfaction<br>* Patient satisfaction evaluated by Womac reduced Score<br>Other: Efficacity<br>* Efficacity as evaluated by Harris HIP score<br>Other: Radiographic evaluation<br>* Bone reaction visible in radiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Innocuity of POLYMAX acetabular implant as assessed by data collected on early complications |  | 60 months | 
| Innocuity of POLYMAX acetabular implant as assessed by data collected on late-stage complications |  | 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacity of POLYMAX acetabular implant as assessed by Harris clinical score |  | 60 months | 
| Patient satisfaction as assessed by Womac reduced score |  | 60 months | 
| Evaluation of implant good holding as assessed by apparition of radiolucent lines in radiography |  | 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acetabular implant