Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
NCT04193163 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 10
Last updated 2026-02-02
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.
Conditions
- Hip Disease
- Hip Fractures
Interventions
- 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.
Sponsors & Collaborators
-
FH ORTHO
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-12-01
- Primary Completion
- 2022-09-01
- Completion
- 2022-09-01
- FDA Device
- Yes
Countries
- France
Study Locations
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