NCT04193163

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: FH ORTHO · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hip Disease
• Hip Fractures

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2019-12-10
• Last updated: 2026-02-02

Locations

7 sites across 1 country: France

Regulatory

• FDA-regulated device study