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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TERMINATED
743 participants
OBSERVATIONAL
2015-01-31
2022-10-31
Brief Summary
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This study aims to assess performance, clinical outcomes and safety
Detailed Description
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Patient specific rods were created by Medicrea to address this gap and support surgeons in achieving what they planned to perform in terms of spinal correction based on preoperative X-rays analyses.
Beside to help surgeons in planning and to improve performance, the avoidance of manual bending is supposed to save time during surgery and to limit notches which should then reduce rod fractures responsible for surgical revisions.
A European register-like study has been set-up to assess radiological performance, clinical outcomes and revision rate following implantation of patient-specific rods in adult spinal deformities
Conditions
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Keywords
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Study Design
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COHORT
OTHER
Study Groups
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Pediatric patients operated with Patient-specific rods
Patients with patient-specific rods (UNiD Rods) \<18Years old
UNiD Rods
Spinal osteosynthesis
Adult patients operated with Patient-specific rods
Patients with patient-specific rods (UNiD Rods) \>18Years old
UNiD Rods
Spinal osteosynthesis
Interventions
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UNiD Rods
Spinal osteosynthesis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient affiliated to health care insurance (social security in France)
* Patient able to complete a self-administered questionnaire
* Patient able to sign a disclosure form or a non-opposition form
Exclusion Criteria
* Pregnant patient
* Patient not affiliated to health care insurance (social security in France)
* Patient unable to sign a disclosure form
* Patient unable to complete a self-administered questionnaire
ALL
No
Sponsors
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Medicrea International
INDUSTRY
Responsible Party
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Principal Investigators
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Vincent Fiere, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Orthopédique Santy
Locations
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CH WAPI
Tournai, , Belgium
Polyclinique
Bordeaux, , France
Orthopôle
Bruges, , France
CHU Estaing
Clermont-Ferrand, , France
Hopital Saint Philibert
Lomme, , France
Centre Orthopédique Santy
Lyon, , France
Les Massues
Lyon, , France
Hopital la Timone
Marseille, , France
Hopitaux pediatriques - CHU Lenval
Nice, , France
Hopital Trousseau
Paris, , France
La pitié Salepetrière Hospital
Paris, , France
Saint Etienne Hospital
Saint-Etienne, , France
Pr Andrzej Maciejczak
Tarnów, , Poland
Countries
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Other Identifiers
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1501
Identifier Type: -
Identifier Source: org_study_id