Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring

Study Overview
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Brief Summary
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The SPINEREG study is a prospective observational registry. Eligible patients are subjects undergoing spine surgery at the participating institutions. Baseline health status and follow-up health status are recorded at pre-established steps.

Detailed Description
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The SPINEREG study is a prospective observational study. Eligible patients are subjects undergoing spine surgery at the participating institutions. Baseline health status and follow-up health status are recorded at pre-established steps. Data from surgery and patients PROMs are registered on the database; the main timepoints are: pre-surgery, surgery, 3-6 month after surgery, 1-2-5-10-15-20 years after surgery.

Official Title
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Galeazzi Spine Registry: Prospective Study for Clinical Monitoring of Patients Undergoing Spine Surgery

Conditions
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Scoliosis, Patients Undergoing Spine Surgery, Disc Disease, Disc Injury, Myelopathy, Spinal Stenosis, SPINAL Fracture, Spinal Fusion

Intervention / Treatment
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* Other: Spine Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing spine surgery in the participating centers Exclusion Criteria: Patients only in conservative treatment Patients to refuse to enter the study

Ages Eligible for Study
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Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Spine Surgery|Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal function (Oswestry Disability Index score) | Oswestry Disability Index score (ODI). Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability. The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible. | 1 years | 
| Reliability of the data collected in SpineReg | This project was based on the retrospective analysis of patients prospectively enrolled in a spinal surgery registry, SpineREG. The study aims to evaluate the equivalence of the PROMs registered in SpineREG using two different formats: paper vs. electronic version. Through the comparison between the data electronically provided in SpineREG and the paper questionnaires, the accuracy, reliability and validity of the data were evaluated. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scoliosis, disc disease, spinal fracture, spinal fusion, spine surgery, registry