Prospective Study for the Evaluation of the Cementless Anatomic Femoral Stem Minimax -Launay

Study Overview
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Brief Summary
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This is a post-marketing surveillance on MiniMAX Stem

Official Title
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Prospective, Multricentre, Non Controlled, Non-randomized, Open Study for the Evaluation of the Cementless Anatomic Femoral Stem MiniMAX

Conditions
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Primary Osteoarthritis, Secondary Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis, Fracture; Femur, Head

Intervention / Treatment
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* Device: MiniMAX


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a clinical condition requiring THA Patient receiving a MiniMAX® stem Patient aged more than 18 years Patient having a Social Insurance or a similar protection regime Patient eligible for an AMIS procedure Patient able to follow the study requirements Patients who are willing to give informed written consent Exclusion Criteria: Patient with local or systemic infection Participation to biomedical research Patient whose BMI exceeds 40 Patient with less than 18 years Protected adults Vulnerable person according to article L1121-6 of the Code de la Santè Publique. Pregnant or lactating woman Patient unable to express his/ her opinion about the participation to the study

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

| Intervention/Treatment |
| --- |
|Device: MiniMAX|Total or Partial Hip Arthroplasty|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate | Kaplan Meier method | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional evaluation | Harris Hip Score (HHS): the HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: <70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent. | Pre-op, 3 months, 1, 3, 5, 10 years | 
| Evaluation of patient satisfaction | HOOS (hip disability and osteoarthritis outcome score) questionnaire: HOOS is a questionnaire intended to be used to assess patient's opinion about their hip and associated problems, and to evaluate their symptoms and functional limitations during a therapeutic process.The interval score ranges from 0 to 100 where 0 represents total hip disability and 100 represents perfect hip health. | Pre-op, 3 months, 1, 3, 5, 10 years | 
| Evaluation of the stem fixation | Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines. | Pre-op, 3 months, 1, 3, 5, 10 years | 
| Evaluation of the general and thigh pain | Echelle Visuelle Analogique (EVA) and pain location. Interpretation of the EVA scale: no pain 0, low pain 1-3, moderate pain 4-6, severe pain 7-9, extreme pain 10. | Pre-op, 3 months, 1, 3, 5, 10 years | 
| Incidence of adverse events | Intraoperative and postoperative complications | Surgery, Immediate post-op, 3 months, 1, 3, 5, 10 years | 
| Evaluation of the stability of the stem | Radiographic evaluation to assess the osteointegration of the stem, the implant positioning, radiolucent lines. | Pre-op, 3 months, 1, 3, 5, 10 years |