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Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring (SPINEREG)

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ClinicalTrials.gov Identifier: NCT03644407
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Patients Undergoing Spine Surgery Scoliosis Disc Disease Disc Injury Myelopathy Spinal Stenosis SPINAL Fracture Spinal Fusion Other: Spine Surgery

Detailed Description:

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.

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Galeazzi Spine Registry: Prospective Study for Clinical Monitoring of Patients Undergoing Spine Surgery
Actual Study Start Date : November 10, 2015
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025
Groups and Cohorts
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Intervention Details:
  • Other: Spine Surgery
    Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry

Outcome Measures
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Primary Outcome Measures :
  1. Spinal function (Oswestry Disability Index score) [ Time Frame: 1 years ]
    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.

  2. Reliability of the data collected in SpineReg [ Time Frame: 6 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who undergo spine surgery in the participating centers and give informed consent to participate
Criteria

Inclusion Criteria:

  • Patients undergoing spine surgery in the participating centers

Exclusion Criteria:

  • Patients only in conservative treatment
  • Patients to refuse to enter the study
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03644407


Contacts
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Contact: PEDRO BERJANO, MD PHD +393395982949 pberjano@gmail.com
Contact: Elena Cittera 39 0266214048 elena.cittera@grupposandonato.it

Locations
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Italy
IRCCS Istituto Ortopedico Galeazzi Recruiting
Milano, Italy, 20161
Contact: Elena Cittera    +390266214057    elena.cittera@grupposandonato.it   
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
More Information
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Additional Information:

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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT03644407    
Other Study ID Numbers: SPINEREG
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Istituto Ortopedico Galeazzi:
registry
scoliosis
disc disease
 spinal fracture
spinal fusion
spine surgery
Additional relevant MeSH terms:
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Scoliosis
Spinal Stenosis
Spinal Cord Diseases
Spinal Fractures
Fractures, Bone
Wounds and Injuries
Spinal Curvatures
 Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Central Nervous System Diseases
Nervous System Diseases
Spinal Injuries
Back Injuries