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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04193163
Other study ID # 2018-37
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2019
Est. completion date December 1, 2030

Study information

Verified date December 2019
Source FH Orthopedics
Contact Clinical Project Leader
Phone 0033389818827
Email n.mathias@groupe-fh.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 268
Est. completion date December 1, 2030
Est. primary completion date December 1, 2030
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
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 Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
France Clinique Tivoli Ducos Bordeaux
France Nouvelle Clinique Bel-Air Bordeaux
France CH Pasteur Colmar
France Clinique du Val d'Ouest Écully
France CH Raymond POINCARE Garches
France CH de Haguenau Haguenau
France Groupe Hospitalier Pitié-Salpêtrière Paris

Sponsors (1)

Lead Sponsor Collaborator
FH Orthopedics

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Survival rate 10 years post-op
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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