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

Hip Fractures Clinical Trial

— ESOP2  

Official title:

Prospective Observational Clinical Study Conducted Over a 10-year Period on Patients Who Received the ESOP 2 Stem to Restore Joint Function, in Order to Confirm Security and Performance of the Device

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04193163
• Other study ID #: 2018-37
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Hip Disease
• Hip Fractures

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