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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

Description

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.

Eligibility

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

Study details
    Hip Disease
    Hip Fractures

NCT04193163

FH ORTHO

27 January 2024

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