Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device (ESOP2)

FH ORTHO

Status

Enrolling

Conditions

Hip Fractures

Hip Disease

Treatments

Device: Hip prosthesis - ESOP 2 cementless femoral stem

Study type

Observational

Funder types

Industry

Identifiers

NCT04193163

2018-37

Details and patient eligibility

About

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.

Full 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.

Enrollment

268 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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