Hip Fractures Clinical Trial
— ESOP2Official 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
NCT number | NCT04193163 |
Other study ID # | 2018-37 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2019 |
Est. completion date | December 1, 2030 |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
FH Orthopedics |
France,
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 |
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