Status:

RECRUITING

The SPINUS II Study: Spinal Fusion for Multilevel SPECT/CT Positive Lumbar Degeneration

Lead Sponsor:

Military University Hospital, Prague

Collaborating Sponsors:

University Hospital, Motol

Conditions:

Degenerative Disc Disease

Back Pain Lower Back Chronic

Eligibility:

All Genders

18-75 years

Brief Summary

The aim of the present study is to find out whether fusion of multilevel SPECT/CT positive lumbar degeneration leads to a significant improvement of pain and disability.

Detailed Description

Chronic back pain (CBP) is a very common clinical problem. It is dominantly caused by degenerative changes, while specific causes such as tumor, trauma or inflammatory conditions are relatively rare. ...

Eligibility Criteria

Inclusion

  • Lower back pain (in extension +/- pain in buttocks, groin, thigh) without radicular pain
  • Symptoms \> 6 months after the failure of conservative management in the primary care setting
  • MRI signs of degenerative disc disease or facet arthropathy
  • Two- or more levels of positivity on lumbar SPECT/CT

Exclusion

  • Other spinal pathology (tumors, congenital defects, spondylolysis, or spondylolisthesis)
  • Intolerance of SPECT examination
  • Pregnancy

Key Trial Info

Start Date :

June 1 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT04893720

Start Date

June 1 2021

End Date

June 1 2026

Last Update

March 13 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Military University Hospital Prague

Prague, Czechia, 16902

2

University Hospital, Motol

Prague, Czechia

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