N/A
N=42
Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems
Hip Arthropathy
Bottom Line
View on ClinicalTrials.gov: NCT06096168 ↗Enrolled (actual)
42
Serious AEs
9.5%
Results posted
Jun 2025
Primary outcome: Primary: Survival Rate at Mid Term Follow-up — 90.1 percentage of implant survival
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Societe dEtude, de Recherche et de Fabrication
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Rate at Mid Term Follow-up |
90.1 | — |
| SECONDARY Adverse Events |
1; 1; 1; 1; 1 | — |
| SECONDARY Survival Rates at Mid Term Follow-up (by Component) |
100 | — |
| SECONDARY Survival Rates at Mid Term Follow-up (by Etiology) |
80 | — |
| SECONDARY Patient's Satisfaction |
4; 4; 2; 0; 0 | — |
| SECONDARY Oblivion of Prosthesis |
80.4 | — |
| SECONDARY Functional Improvement |
71.5 | — |
Summary
This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.
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.
Eligibility Criteria
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 01/01/2016 and 31/12/2018,
- Affiliated to French health insurance system
Exclusion Criteria
- Patient who has not expressed consent for data collection and participation in the study,
- Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
- Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
- Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication
Data sourced from ClinicalTrials.gov (NCT06096168). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.