NCT03644407

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2015

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 25, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

9.2 years

First QC Date

April 25, 2018

Last Update Submit

January 23, 2020

Conditions

Patients Undergoing Spine SurgeryScoliosisDisc DiseaseDisc InjuryMyelopathySpinal StenosisSPINAL FractureSpinal Fusion

Keywords

registryscoliosisdisc diseasespinal fracturespinal fusionspine surgery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 months

Interventions

Spine SurgeryOTHER

Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry

Eligibility Criteria

AgeUp to 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who undergo spine surgery in the participating centers and give informed consent to participate

You may qualify if:

  • Patients undergoing spine surgery in the participating centers

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, 20161, Italy

RECRUITING

Related Publications (2)

  • 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: 40142224DERIVED

  • 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: 37000218DERIVED

MeSH Terms

Conditions

ScoliosisSpinal Cord DiseasesSpinal StenosisSpinal Fractures

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal InjuriesBack InjuriesWounds and InjuriesFractures, Bone

Central Study Contacts

PEDRO BERJANO, MD PHD

CONTACT

+393395982949pberjano@gmail.com

Elena Cittera

CONTACT

39 0266214048elena.cittera@grupposandonato.it

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2018

First Posted

August 23, 2018

Study Start

November 10, 2015

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

IT(1)