Hip Disease, Hip Fractures
Conditions
Keywords
Arthroplasty, Hip replacement
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.
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.
Interventions
DEVICEHip 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
FH ORTHO
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate | 10 years post-op |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographies evaluation | immediate post-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | Radiological results such as stability, osteointegration will be evaluated. |
| Rate of complications | per-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | All complications will be gathered during intervention and up to 10 years postoperatively. |
| Functional outcomes such as pain, mobility | pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | 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. |
| Quality of life evaluation | pre-op, 3 months post-op, 1 year post-op, 5 years post-op, 10 years post-op | 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. |
Countries
France
Outcome results
None listed