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

Scoliosis Clinical Trial

— SPINEREG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03644407
• Other study ID #: SPINEREG
• Status: Recruiting
• Start date: November 10, 2015
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2020
• Source: Istituto Ortopedico Galeazzi
• Contact: PEDRO BERJANO, MD PHD
• Phone: +393395982949
• Email: pberjano[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 120 Years

Eligibility

Inclusion Criteria:

• Patients undergoing spine surgery in the participating centers

Exclusion Criteria:

• Patients only in conservative treatment

• Patients to refuse to enter the study

Related Conditions & MeSH terms

• Disc Disease
• Disc Injury
• Myelopathy
• Patients Undergoing Spine Surgery
• Scoliosis
• Spinal Cord Diseases
• SPINAL Fracture
• Spinal Fractures
• Spinal Fusion
• Spinal Stenosis

Intervention

Other:
• Spine Surgery
Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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