Predicting Outcomes After Lumbar Fusion for Degenerative Disease

NCT05161130 | Completed

• 1 other identifier: FUSE-ML
• Study Type: observational
• Target: 1,115
• Locations: 3 countries
• Sites: 4

Brief Summary

The aim of the FUSE-ML study is to develop and externally validate a robust ML-based prediction tool based on multicenter data from a range of international centers that will provide individualized risk-benefit profiles tailored to each patient undergoing lumbar spinal fusion for degenerative disease. Data will be collected by a range of international centers.

Conditions

Low Back Pain; Disk Herniated Lumbar; Spinal Stenosis Lumbar

Keywords

machine learning; clinical prediction modeling

Outcome Measures

Primary Outcomes (3)

• Visual Analogue Scale for Back Pain

  Visual Analogue Scale (VAS) for Back Pain Severity from 0 to 100, with higher scores indicating more pain.

  12 months after surgery

• Visual Analogue Scale for Leg Pain

  Visual Analogue Scale (VAS) for Leg Pain Severity from 0 to 100, with higher scores indicating more pain.

  12 months after surgery

• Oswestry Disability Index

  Oswestry Disability Index (ODI) for Subjective Functional Impairment (0 to 100, with higher values indicating higher levels of functional impairment)

  12 months after surgery

Interventions

Lumbar Spinal Fusion PROCEDURE

Lumbar Spinal Fusion with or without posterior stabilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent lumbar spinal fusion for degenerative disease

You may qualify if:

• Degenerative pathologies (one or multiple of the following: spinal stenosis, spondylolisthesis, degenerative disc disease, recurrent disc herniation, failed back surgery syndrome (FBSS), radiculopathy, pseudarthrosis).
• Patients are required to give informed consent.

You may not qualify if:

• Patients undergoing surgery for - as the primary indication - infections, vertebral tumors, as well as traumatic and osteoporotic fractures or deformity surgery for scoliosis or kyphosis are not eligible. Patients with moderate or severe scoliosis (Coronal Cobb's \>30 degrees / Schwab classification sagittal modifier + or ++) are not eligible.
• Patients undergoing surgery at more than 6 vertebral levels are also not eligible.
• Patients with missing endpoint data at 12 months will be excluded.

Sponsors & Collaborators

• Bergman Clinics: lead
• University of Zurich: collaborator

Study Sites (4)

Medical University of Innsbruck

Innsbruck, Austria

Location

La Pitié Salpetrière Hospital

Paris, France

Location

Department of Neurosurgery, Bergman Clinics

Naarden, 1411 GE, Netherlands

Location

Bergman Clinics

Naarden, GE, Netherlands

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc L Schröder, MD PhD

  Bergman Clinics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director, Senior Neurosurgeon, Department of Neurosurgery

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 16, 2021
• Study Start: January 1, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FR (1); NL (2)