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

N/ATerminatedNCT04193163

FH ORTHO10 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hip Disease Hip Fractures

Interventions

Hip prosthesis - ESOP 2 cementless femoral stemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Clinique Tivoli Ducos

Bordeaux, France

Nouvelle Clinique Bel-Air

Bordeaux, France

CH Pasteur

Colmar, France

Clinique du Val d'Ouest

Écully, France

Outcomes

Primary Outcomes

Survival rate

Time frame: 10 years post-op

Secondary Outcomes

Radiographies evaluation

Radiological results such as stability, osteointegration will be evaluated.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op

Data from ClinicalTrials.gov

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