Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device

Study Overview
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Brief Summary
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This study is a post-market clinical follow-up conducted in order to collect long-term data on security and performance of the ESOP 2 stem, which is intended to be implanted in case of total hip replacement, when used in real life conditions according to the instructions for use.

Detailed Description
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The primary objective of this study is to evaluate the security of the ESOP 2 stem by calculating the survival rate up to 10 years of follow-up. The secondary objectives are to evaluate the security and performance of the device by assessing radiological data, gathering complications and evaluating functional score and quality of life score up to 10 years of follow-up.

Official Title
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Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device

Conditions
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Hip Disease, Hip Fractures

Intervention / Treatment
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* Device: Hip prosthesis - ESOP 2 cementless femoral stem


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject implanted with ESOP 2 stem in one of the following indication according to the instructions for use: hip disorders; femoral neck fracture Subject who received an information form and is willing to participate in the study Exclusion Criteria: Contraindications described in the instructions for use Usual surgical contraindications Subject who is not able to express his/her non-opposition

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 receiving ESOP 2 stem<br> | Device: Hip prosthesis - ESOP 2 cementless femoral stem<br>* ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate |  | 10 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographies evaluation | Radiological results such as stability, osteointegration will be evaluated. | immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | 
| Rate of complications | All complications will be gathered during intervention and up to 10 years postoperatively. | per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | 
| Functional outcomes such as pain, mobility | Functional outcomes will be determined by the Harris Hip score. This score ranges from 0 to 100, where, the higher the score, the better the patient outcome. | pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | 
| Quality of life evaluation | Quality of life will be determined by the OXFORD-12 score. This score ranges from 12 points to 60 points, where, the higher the score, the better the patient outcome. | pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arthroplasty, Hip replacement