Total Hip Arthroplasty (THA)
Conditions
Brief summary
XPEO-E liner is CE marked under MDD 93/42/CEE by equivalency with CI E liner. No pertaining data on XPEO-E liner is yet available. However, clinical evaluation concludes on a reaching of performance and safety and compliance with essential requirements. This study intends to collect data on XPEO-E in order to allow a transit to MDR 2017/745 (EU). XPEO-E liner is intended to be used with NOVAE cups and SERF femoral heads and Stems. XPEO-E liner will be used according to their CE marking. These devices are intended for hip replacements with the aim of improving quality of life and reducing pain by replacing a damaged joint. The follow-up visits are established according to the current practice. Additional procedure will only consist on questionnaires that will be filled by the patient and/or the surgeons.
Interventions
None listed
Sponsors
Societe dEtude, de Recherche et de Fabrication
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* Male or female adults. * Patient that needs to be implanted with a SERF total hip prosthesis. * Patient responding to IFU requirement. * Patient affiliated to French social security. * Patient who has provided a dated and signed informed consent form.
Exclusion criteria
* Patient protected by a French legal measure (under legal protection, guardianship or curatorship). * Patient unable of expressing consent, according to the investigator. * Patient deprived of liberty or hospitalized against his consent. * Pregnant or breastfeeding patient. * Patient presenting a contraindication to the implantation of medical devices according to the instructions for use. * Patient with a contraindication to radiographic follow-up. * Patient not being, a priori, capable of respecting the schedule of follow-up visits, according to the investigator. * Patient unable to complete a self-questionnaire, according to the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional improvement | Per operative period to 5 years | To assess the evolution of patient's functional capacity post-implantation using Harris Hips score (measured from 0 to 100 points, the higher the score the better the outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival rate | Per operative period to 5 years | Calculated using the Kaplan-Meier method |
| Functional improvement | Per operative period to 5 years | To assess the evolution of patient's functional capacity post-implantation using HOOS score (40-item questionnaire mesured from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms ) |
| Pain release | Pre operative period to 5 years | To assess patient's pain (Visual Analogic Scale measured on a scale of 0 to 10 to reflect the intensity of the pain) |
| Patient's quality of life | Pre operative period to 5 years | To assess patient's quality of life post-implantation (Forgotten Joint Score mesured from 0 to 100, the higher the score, the less the patient is aware of their affected joint when performing daily activities) |
| Patient's satisfaction | Post operative period to 5 years | To assess patients' satisfaction with the operation (4-points question) |
| Adverse events | Per operative period to 5 years | To assess the long-term safety of investigational medical devices as well as post-operative safety of the surgery |
Countries
France
Contacts
CONTACTClinical department
Outcome results
None listed