Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-13

Study Completion Date

2024-10-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Hip Arthropathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No