Galeazzi Spine Registry: Prospective Study for Clinical Monitoring of Patients Undergoing Spine Surgery
| Registry | NCT03644407, acronym SPINEREG |
|---|
| Status | Unknown |
|---|
| Study type | Observational |
|---|
| Enrollment | 10000 (Estimated) |
|---|
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio (Other) |
|---|
| Conditions | Patients Undergoing Spine Surgery, Scoliosis, Disc Disease, Disc Injury, Myelopathy, Spinal Stenosis, SPINAL Fracture, Spinal Fusion |
|---|
| Interventions | Spine Surgery (Other) |
|---|
| Dates | start 2015-11-10, primary completion 2025-01-01 (estimated), completion 2025-01-01 (estimated), first posted 2018-08-23, last updated 2020-01-27 |
|---|
| Locations | 1 site in Italy |
|---|
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Patients Undergoing Spine Surgery All trials for Scoliosis All trials of Spine Surgery
-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.
Expand all sections · Collapse all
+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.
+Arms and interventions
- Spine Surgery (Other): Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry
+Outcome measures
Primary outcomes
- 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.
+Eligibility
Sex: All, ages: any to 120 Years
Inclusion Criteria:
* Patients undergoing spine surgery in the participating centers
Exclusion Criteria:
* Patients only in conservative treatment
* Patients to refuse to enter the study
+Locations (1)
| Facility | City | Country | Status |
|---|
| IRCCS Istituto Ortopedico Galeazzi | Milan | Italy | Recruiting |
+Publications
- Results publication: Briguglio M, Campagner A, Langella F, Cecchinato R, Damilano M, Bellosta-Lopez P, Crespi T, De Vecchi E, Latella M, Barone G, Scaramuzzo L, Bassani R, Luca A, Brayda-Bruno M, Wainwright TW, Middleton RG, Lombardi G, Cabitza F, Banfi G, Berjano P. Malnutrition and Disability: A Retrospective Study on 2258 Adult Patients Undergoing Elective Spine Surgery. Medicina (Kaunas). 2025 Feb 26;61(3):413. doi: 10.3390/medicina61030413. PMID 40142224
- Results publication: Bassani R, Morselli C, Cirullo A, Pezzi A, Peretti GM. A novel less invasive endoscopic-assisted procedure for complete reduction of low-and high-grade isthmic spondylolisthesis performed by anterior and posterior combined approach. Eur Spine J. 2023 Aug;32(8):2819-2827. doi: 10.1007/s00586-023-07666-9. Epub 2023 Mar 31. PMID 37000218