Hip Arthropathy
Conditions
Keywords
Total Hip Prosthesis Revision
Brief summary
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices. The primary objective is to evaluate the long-term survival rate (7 to 10 years post-op +/- 2 years) of SAGITTA EVL R stems. Secondary objectives are to : * study long term patient satisfaction with their hip prosthesis, * confirm the long-term safety of these implants by studying the possible complications observed, * evaluate the performance of these implants using clinical scores.
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
Healthy volunteers
No
Inclusion criteria
* Patient over 18 years old at the time of surgery, * Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2010 and 31/12/2015, * Affiliated to French health insurance system
Exclusion criteria
* Patient who has rejected to the use of his/her personal data, * Patient unable to understand the surgeon's instructions or to carry out the post-operative follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival Rate at Mid/Long Term Follow-up | At 7/10 years after surgery | Assess the survival rate at 7/10 year-follow-up, whatever the cause of revision |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient's Satisfaction | At 7/10 years after surgery | Assessed by the surgeon through questionary with a 5 item-scale : very satisfied / satisfied / neither satisfied - nor unsatisfied / unsatisfied / very unsatisfied |
| Adverse Events | At 7/10 years after surgery | List type and occurence of adverse events |
| Oblivion of Prosthesis | At 7/10 years after surgery | Assess the degree of forgetfulness of the prosthesis using FJS-score : FJS stands for Forgotten Joint Score. The Forgotten Joint Score assessment consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities |
| Absence of Squeaking | At 7/10 years after surgery | Number of patients experiencing no squeaking |
| Functional Improvement | At 7/10 years after surgery | The only measure to be considered is "Modified Harris Hip Score" which consists of a 0 to 100 points scale (100 points is the better outcome). The data retrieved from site is only 1 figure ranging from 0 to 100. |
Countries
France
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 79 years STANDARD_DEVIATION 7.44 |
| Hip side left | 18 number of implants |
| Hip side right | 28 number of implants |
| Race/Ethnicity, Customized French nationality | 46 number of implants |
| Region of Enrollment France | 46 number of implant |
| Sex: Female, Male Female | 27 number of implants |
| Sex: Female, Male Male | 19 number of implants |
| Size | 166 cm STANDARD_DEVIATION 9.5 |
| Weight | 74.9 kg STANDARD_DEVIATION 19.2 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 23 / 43 |
| other Total, other adverse events | 8 / 46 |
| serious Total, serious adverse events | 15 / 46 |
Outcome results
None listed