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

Recruiting

• Conditions: Patients Undergoing Spine Surgery; Disc Disease; Disc Injury; Spinal Stenosis; SPINAL Fracture; Spinal Fusion; Myelopathy; Scoliosis

• Registration Number: NCT03644407
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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.

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 Timeline

• Study Start: 2015-11-10
• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-23
• Last Update Posted: 2020-01-27
• Primary Completion: 2025-01-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Patients undergoing spine surgery in the participating centers

Exclusion Criteria

• Patients only in conservative treatment
• Patients to refuse to enter the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Spinal function (Oswestry Disability Index score)	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.
Reliability of the data collected in SpineReg	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.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Galeazzi; 🇮🇹 Milano, Italy