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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-09-01

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.

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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.

Conditions

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Hip Disease Hip Fractures

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients receiving ESOP 2 stem

Hip prosthesis - ESOP 2 cementless femoral stem

Intervention Type DEVICE

ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.

Interventions

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Hip prosthesis - ESOP 2 cementless femoral stem

ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No