Galeazzi Spine Registry: Prospective Study for Clinical Monitoring of Patients Undergoing Spine Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Patients Undergoing Spine Surgery
- Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Enrollment
- 10000
- Locations
- 1
- Primary Endpoint
- Spinal function (Oswestry Disability Index score)
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
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.
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.