Study Stopped
Discontinuation of the studied medical device on the market and not enough inclusion in the study.
Observational Study Conducted on Patients Receiving the ESOP 2 Stem to Confirm Security and Performance of the Device
ESOP2
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
1 other identifier
observational
10
1 country
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2019
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2019
CompletedStudy Start
First participant enrolled
December 1, 2019
CompletedFirst Posted
Study publicly available on registry
December 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedFebruary 2, 2026
January 1, 2026
2.8 years
November 28, 2019
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate
10 years post-op
Secondary Outcomes (4)
Radiographies evaluation
immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Rate of complications
per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Functional outcomes such as pain, mobility
pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Quality of life evaluation
pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op
Study Arms (1)
Patients receiving ESOP 2 stem
Interventions
ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.
Eligibility Criteria
Patients from participating hospitals will be enrolled as part of their clinical routine care.
You may qualify if:
- 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
You may not qualify if:
- Contraindications described in the instructions for use
- Usual surgical contraindications
- Subject who is not able to express his/her non-opposition
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- FH ORTHOlead
Study Sites (7)
Clinique Tivoli Ducos
Bordeaux, 33000, France
Nouvelle Clinique Bel-Air
Bordeaux, 33000, France
CH Pasteur
Colmar, 68024, France
Clinique du Val d'Ouest
Écully, 69130, France
CH Raymond POINCARE
Garches, 92380, France
CH de Haguenau
Haguenau, 67504, France
Groupe Hospitalier Pitié-Salpêtrière
Paris, 75651, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2019
First Posted
December 10, 2019
Study Start
December 1, 2019
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share