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

NCT04893720 | Recruiting

• 1 other identifier: SPINUS-UVN II
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Degenerative Disc Disease; Back Pain Lower Back Chronic; Facet Joint Arthropathy; Facet Syndrome of Lumbar Spine

Outcome Measures

Primary Outcomes (2)

• Change 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 100). Zero is equated with no disability and 100 is the maximum disability possible.

  2 years

• Change 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 lumbar degeneration

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 levels 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 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

You may not qualify if:

• Other spinal pathology (tumors, 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

RECRUITING

University Hospital, Motol

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Jaroslav Plas

  jaroslav.plas@uvn.cz

  STUDY CHAIR

Central Study Contacts

Radek Kaiser

CONTACT

+420607545132; rkaiser@hotmail.cz

Jaroslav Plas

CONTACT

jaroslav.plas@uvn.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: May 19, 2021
• Study Start: June 1, 2021
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2)