Ambispective Study to Assess the Safety and the Performance of SAGITTA EVL R Stem
NCT ID: NCT06096155
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
61 participants
OBSERVATIONAL
2023-06-13
2024-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 unable to understand the surgeon's instructions or to carry out the post-operative follow-up.
18 Years
ALL
No
Sponsors
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Societe dEtude, de Recherche et de Fabrication
INDUSTRY
Responsible Party
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Locations
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Centre Hospitalier Loire Vendée Océan
Challans, Vendée, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-09_Sagitta EVL-R
Identifier Type: -
Identifier Source: org_study_id
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