Disc Disease, Disc Injury, Myelopathy, Patients Undergoing Spine Surgery, Scoliosis, SPINAL Fracture, Spinal Fusion, Spinal Stenosis
Conditions
Keywords
registry, scoliosis, disc disease, spinal fracture, spinal fusion, spine surgery
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.
Interventions
OTHERSpine Surgery
Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry
Sponsors
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing spine surgery in the participating centers
Exclusion criteria
* Patients only in conservative treatment * Patients to refuse to enter the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactPEDRO BERJANO, MD PHD
Backup ContactElena Cittera
Outcome results
None listed