Patients Undergoing Spine SurgerySPINEREGNCT03644407
Galeazzi Spine Surgery RegistryGaleazzi Spine Registry: Prospective Study for Clinical Monitoring
An observational study of Patients Undergoing Spine Surgery and Scoliosis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Patients Undergoing Spine Surgery, Scoliosis, Disc Disease
- What is being tested?
- Spine Surgery
- How many people
- 10,000 participants
- Where
- 1 siteItaly
- Study dates
- 10 Nov 2015to 1 Jan 2025
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients who undergo spine surgery in the participating centers and give informed consent to participate
Who may be able to join
- Patients undergoing spine surgery in the participating centers
Who cannot join
- Patients only in conservative treatment
- Patients to refuse to enter the study
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Elena Cittera, +390266214057, elena.cittera@grupposandonato.it
About this study
Official title: Galeazzi Spine Registry: Prospective Study for Clinical Monitoring of Patients Undergoing Spine Surgery
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.
Read the 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.
- Conditions
- Patients Undergoing Spine Surgery, Scoliosis, Disc Disease, Disc Injury, Myelopathy, Spinal Stenosis
- Being tested
- Spine Surgery
- Keywords
- registry, scoliosis, disc disease, spinal fracture, spinal fusion, spine surgery
- Medical subject headings
- Scoliosis, Spinal Cord Diseases, Spinal Stenosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine SurgeryOther
Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 years
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start10 Nov 2015
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing Spine SurgeryStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644407
- Sponsor's protocol ID
- SPINEREG
- Acronym
- SPINEREG
- Status last verified
- Jan 2020
- First submitted
- 25 Apr 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40142224Bassani 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.
PubMed 37000218
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Galeazzi Spine Registry: Prospective Study for Clinical Monitoring of Patients Undergoing Spine Surgery
- ClinicalTrials.gov ID
- NCT03644407
- Acronym / sponsor ID
- SPINEREG / SPINEREG
- Conditions
- Patients Undergoing Spine Surgery, Scoliosis, Disc Disease, Disc Injury, Myelopathy, Spinal Stenosis
- Keywords
- registry, scoliosis, disc disease, spinal fracture, spinal fusion, spine surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 10 Nov 2015 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients who undergo spine surgery in the participating centers and give informed consent to participate
Key inclusion criteria (1 listed)
- Patients undergoing spine surgery in the participating centers
Key exclusion criteria (2 listed)
- Patients only in conservative treatment
- Patients to refuse to enter the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spine SurgeryPatients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry | Other | – |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 40142224Briguglio 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.
- Derived from this study: PubMed 37000218Bassani 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Undergoing Spine Surgery and Scoliosis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PEDRO BERJANO, MD PHD (+393395982949, pberjano@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spinal function (Oswestry Disability Index score) (time frame: 1 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03644407, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.