Observational follow-up on the ESOP 2 hip replacement 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
This study is tracking how well the ESOP 2 hip replacement device works and how safe it is for people over a period of up to 10 years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 268 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fh Ortho Industry-sponsored |
| Locations | 7 sites (Bordeaux and 6 other locations) |
| Trial ID | NCT04193163 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect long-term data on the security and performance of the ESOP 2 stem used in total hip replacements. It will evaluate the survival rate of the device over a follow-up period of up to 10 years. Additionally, the study will assess radiological data, complications, functional scores, and quality of life scores to provide a comprehensive evaluation of the device's effectiveness in real-life conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who have been implanted with the ESOP 2 stem for hip disorders or femoral neck fractures.
Not a fit: Patients with contraindications to the ESOP 2 stem or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of the ESOP 2 hip replacement device for patients with hip disorders.
How similar studies have performed: Other observational studies on hip replacement devices have shown success in evaluating long-term outcomes, suggesting this approach is validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux and 6 other locations
- Clinique Tivoli Ducos — Bordeaux, France (Recruiting)
- Nouvelle Clinique Bel-Air — Bordeaux, France (Recruiting)
- CH Pasteur — Colmar, France (Recruiting)
- CH Raymond POINCARE — Garches, France (Not_yet_recruiting)
- CH de Haguenau — Haguenau, France (Not_yet_recruiting)
- Groupe Hospitalier Pitié-Salpêtrière — Paris, France (Recruiting)
- Clinique du Val d'Ouest — Écully, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Clinical Project Leader
- Email: n.mathias@groupe-fh.fr
- Phone: 0033389818827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.