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Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem

NCT06096155 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 61

Last updated 2024-03-04

No results posted yet for this study

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.

Conditions

  • Hip Arthropathy

Sponsors & Collaborators

  • Societe dEtude, de Recherche et de Fabrication

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-13
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06096155 on ClinicalTrials.gov