The SPINUS I Study: Spinal Fusion for a Single Level SPECT/CT Positive Lumbar Degenerative Disc Disease

NCT04876586 | Completed

• 1 other identifier: SPINUS-UVN
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of the present study is to find out whether fusion of a sinlge level SPECT/CT positive degenerative disc disease leads to a significant improvement of pain and disability.

Conditions

Degenerative Disc Disease; Back Pain, Low

Outcome Measures

Primary Outcomes (2)

• Improvement in Oswestry Disability Index (ODI)

  The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire. The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. he scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 10). Zero is equated with no disability and 10 is the maximum disability possible.

  2 years

• Improvement in Pain Visual Analogue Scale (VAS)

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between VAS 0 (no pain) and VAS 10 (worst pain).

  2 years

Interventions

Lumbar fusion PROCEDURE

Transforaminal Lumbar Interbody Fusion of the SPECT/CT positive degenerative disc disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An open prospective cohort study will be performed. Inclusion criteria will be: subjects between 18 and 75 years of age; both genders; with CBP and diagnosis of DDD or facet arthropathy on MRI and increased metabolic activity on bone SPECT/CT imaging in the same level(s) who are undergoing open lumbar interbody fusion. New MRI of the lumbar spine and SPECT/CT will be performed 2 years after the surgical procedure. The patients will complete ODI and VAS questionnaires before surgery and at 6- and 24-months follow-up visits. All patients will sign an informed consent form.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Military University Hospital, Prague: lead
• University Hospital, Motol: collaborator

Study Sites (2)

Military University Hospital Prague

Prague, 16902, Czechia

Location

University Hospital, Motol

Prague, Czechia

Location

Related Publications (1)

• Kaiser R, Varga M, Lang O, Waldauf P, Vanek P, Saur K, Benes V, Netuka D. Spinal fusion for single-level SPECT/CT positive lumbar degenerative disc disease: the SPINUS I study. Acta Neurochir (Wien). 2023 Sep;165(9):2633-2640. doi: 10.1007/s00701-023-05666-8. Epub 2023 Jun 22.

  PMID: 37347294 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Low Back Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaroslav Plas

  Military University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radek Kaiser, MD, PhD

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 6, 2021
• Study Start: January 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: February 1, 2023
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)