Assessment of Patient Inclusion Feasibility for Fusion Targets in the Spine via SPECT/CT

A Monocenter Pilot Study

Study Overview

Study Purpose

This prospective pilot study evaluates the use of SPECT/CT bone scan imaging to identify appropriate surgical targets for spinal fusion in patients with degenerative disorders. The primary goal is to assess patient inclusion feasibility for a potential future multi-center trial.

Principal Investigator

David Werner, MD, PhD
Department of Neurosurgery
Stavanger University Hospital
Email: david.werner@sus.no

Study Design

This is a prospective, open-label, monocentre feasibility trial conducted at Stavanger University Hospital in collaboration between the Neurosurgical and Orthopaedic departments.

Study Setting

Monocentre trial at Stavanger University Hospital (Neurosurgery & Orthopaedics)

Patient Population

Adults aged 18-75 with chronic low back pain or requiring fusion for neural decompression

Imaging Modality

SPECT/CT bone scan to identify high osteoblastic activity zones

Follow-up Period

3 and 12 months post-operative assessments

Background & Methods

Clinical Background

Chronic low back pain is the major cause of disability worldwide. While spinal fusion surgery for back pain remains controversial, recent evidence suggests that SPECT/CT imaging can identify pain generators in the degenerative spine by measuring osteoblastic activity. High intensity zones on SPECT/CT may indicate areas of instability causing pain, potentially predicting which patients will benefit from fusion surgery.

Key Innovation

SPECT/CT combines functional imaging (measuring bone metabolism) with high-resolution anatomical CT imaging, allowing precise localization of potential pain generators in spinal degenerative disease.

Study Objectives

Primary Objective: Assess the potential number of patients that could be included at our unit in a potential multi-center trial (feasibility assessment).

Secondary Objectives: Investigate changes in established outcome measures after lumbar fusion surgery in surgical targets identified by SPECT/CT.

Patient Cohorts

"Back Pain" Cohort

Inclusion: Adults 18-75 with chronic low back pain (>6 months), worse than leg pain, unresponsive to ≥3 months of structured physical therapy.

Treatment: Offered fusion surgery if SPECT/CT shows positive findings (high intensity zones).

"Neural Pain" Cohort

Inclusion: Adults 18-75 with leg pain ≥ back pain, requiring fusion for neural decompression (spondylolysis, spondylolisthesis, facet joint pathology, foraminal stenosis).

Treatment: Undergo fusion surgery regardless of SPECT/CT findings, allowing comparison of outcomes.

Exclusion Criteria

Surgical Intervention

Spinal fusion will be performed using an interbody implant (cage filled with bone graft) with optional posterior instrumentation (pedicle screws and rods). The approach (anterior, lateral, or posterior) will be determined by the surgical team based on individual patient anatomy and pathology.

Safety Considerations

SPECT/CT Radiation: Average exposure is approximately 4.5-5 millisieverts (mSv) per examination.

Surgical Risks: Inherent risks include implant malposition, neurological deficits, infection, pseudoarthrosis, and chronic pain, which will be carefully monitored throughout the study.

Study Outcomes & Measures

Primary Outcome

  • Estimate recruitment rates, refusal rates, and loss to follow-up
  • Assess feasibility for potential multi-center trial

Secondary Outcomes

  • Patient Acceptable Symptom State (PASS): Proportion achieving ODI ≤22 points at 12 months
  • Oswestry Disability Index (ODI): Change in disability score (point and percentage)
  • Pain Scores: Numeric Rating Scale (NRS) for back pain and leg pain
  • Quality of Life: EuroQol 5-Dimensions (EQ-5D)
  • Functional Outcomes: Walking distance, activPAL activity monitoring
  • Return to Work: Where applicable
  • Sagittal Balance: Radiographic assessment
  • Adverse Events: Comprehensive safety monitoring

Data Collection

Patient-reported outcomes will be collected using the Norwegian Registry for Spine Surgery (NORspine) questionnaires. Data will be sent by mail with follow-up contact by the research nurse for non-responders. Functional assessments will be conducted by the research team.

Follow-up Schedule

Baseline

Pre-operative assessment including SPECT/CT imaging and outcome questionnaires

3 Months

First post-operative assessment of outcomes and functional status

12 Months

Final assessment with comprehensive outcome measures

Statistical Analysis

Expected recruitment per year will be estimated with 95% confidence intervals based on the Poisson distribution. Proportions will be reported with 95% Wilson CIs. Mean changes and standard deviations will be reported with 95% CIs based on normal approximation.

Project Progress

✓

Protocol Development

Study protocol finalized and approved by research team

Completed: 2024
✓

Ethics Approval

Ethics approval obtained from Research Ethics Committee (REC)

Completed: 2024
↻

Patient Recruitment

Enrolling patients from neurosurgical and orthopaedic departments

In Progress: 2024-2025
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SPECT/CT Imaging & Surgery

Pre-operative imaging and surgical interventions for enrolled patients

Ongoing during recruitment phase
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Data Collection & Follow-up

3-month and 12-month outcome assessments for all participants

Planned: Throughout study period
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Data Analysis

Statistical analysis of feasibility metrics and clinical outcomes

Planned: Upon completion of follow-ups
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Manuscript Preparation & Dissemination

Publication in open access journal and presentation at scientific meetings

Planned: Following data analysis

Research Team

This collaborative study brings together expertise from neurosurgery, orthopaedics, radiology, rehabilitation medicine, and biostatistics at Stavanger University Hospital and the University of Stavanger.

David Werner

Overlege, PhD

Principal Investigator
Department of Neurosurgery

Stavanger University Hospital

Aksel Paulsen

Overlege, PhD

Section Leader, Research Section
Associate Professor in Orthopedics
Department of Orthopaedic Surgery

Stavanger University Hospital & University of Stavanger

Clemens Weber

Overlege, PhD

Department of Neurosurgery

Stavanger University Hospital

Eric Franssen

Seksjonsoverlege

Department of Orthopaedic Surgery

Stavanger University Hospital

Torjan Haslerud

Seksjonsoverlege NM/PET

Department of Radiology
Nuclear Medicine/PET Section

Stavanger University Hospital

Jan Terje Kvaløy

Professor of Statistics

Department of Mathematics and Physics
Faculty of Science and Technology

University of Stavanger

My Dung Nguyen Torkildsen

Avd. sjef/avd. overlege

Department of Physical Medicine and Rehabilitation

Stavanger University Hospital

Seyedeh Habibeh Fattahi Saravi

Research Nurse

Department of Neurosurgery

Stavanger University Hospital

Oversight & Monitoring

Data Monitoring Committee: Two external clinicians and one biostatistician

Lead Investigator/Sponsor: David Werner, MD, PhD

Supporting Evidence

Our study design is informed by recent published evidence demonstrating the efficacy of SPECT/CT-guided spinal fusion surgery.

The SPINUS I Study

Published Research Foundation

Study: "Spinal fusion for single-level SPECT/CT positive lumbar degenerative disc disease: the SPINUS I study" published in Acta Neurochirurgica (2023) 165:2633-2640

Authors: Radek Kaiser, Michal Varga, Otto Lang, Petr Waldauf, Petr Vaněk, Karel Saur, Vladimír Beneš, David Netuka

Key Finding: The study demonstrated successful outcomes in patients with multi-level degeneration where SPECT/CT imaging identified high uptake zones corresponding to pain generators. Figure 1 from the study shows:

  • A & B: MRI T1W and T2W images showing multi-level degeneration
  • C: SPECT/CT showing higher uptake in L2/3 level (the "hot spot" indicating active bone remodeling)
  • D & E: Post-operative imaging at 6 months and 2 years showing successful fusion of the L2/3 intervertebral space

This validates the concept that SPECT/CT can identify specific levels requiring surgical intervention even in multi-level degenerative disease.

Clinical Outcomes from the SPINUS Study

Published Results Demonstrating SPECT/CT-Guided Fusion Efficacy

Visual Analog Scale (VAS) for Pain:

  • Baseline: Median VAS ~8 (severe pain)
  • 6 months post-surgery: Significant reduction to median ~3
  • 24 months: Sustained improvement maintained at median ~3
  • Individual patient trajectories demonstrate that the majority of patients achieved substantial and durable pain reduction

Oswestry Disability Index (ODI):

  • Baseline: Median ODI ~50 points (severe disability)
  • 6 months: Dramatic improvement to median ~20 points
  • 24 months: Maintained improvement at median ~18 points
  • Most patients achieved clinically meaningful improvement exceeding the minimal clinically important difference

Key Finding: These published results from SPECT/CT-guided single-level lumbar fusion demonstrate that patients with positive SPECT/CT findings achieve significant and sustained improvements in both pain and functional disability. This evidence supports the rationale for our pilot feasibility study.

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Study Protocol

Overview of the study design

SPECT Methodology and Tc-99m

Single Photon Emission Computerized Tomography

Radionuclides and Tissues: SPECT imaging uses Technetium-99m (Tc-99m) as the radiotracer to identify areas of increased osteoblastic activity in the spine. Different radiopharmaceuticals can target specific tissues and metabolic processes.

Generator Methodology: The procedure uses a generator methodology where no Molybdenum-99 (Mo-99) is injected, only Technetium-99m (Tc-99m), ensuring patient safety with targeted imaging.

Apparatus: Modern SPECT/CT scanners combine functional imaging (SPECT) with high-resolution anatomical imaging (CT) to produce detailed tomographic images showing both metabolic activity and anatomical structure.

Study Design Overview

Cohort 1 - "Lassa" (Back Pain)

Inclusion Criteria:

  • Age 18-75 years
  • Back pain > leg pain
  • Minimum 3 months structured physical therapy

Pathway:
SPECT/CT → If Positive → TLIF/ALIF/LLIF fusion surgery

Cohort 2 - "NKIR/ORTO Pol" (Neural Pain)

Inclusion Criteria:

  • Age 18-75 years
  • Surgical indication for fusion based on clinical assessment

Pathway:
SPECT/CT → Positive/Negative → TLIF/ALIF/LLIF fusion surgery

Primary Outcome

Recruitment rate + Loss to follow-up

Secondary Outcomes

  • Proportion of patients achieving ODI ≤ 22 (Patient Acceptable Symptom State)
  • Return to work (where applicable)
  • Change in NRS back pain / leg pain
  • EQ-5D quality of life
  • activePal activity monitoring
  • Sagittal balance
  • Complications

Exclusion Criteria

  • Severe psychiatric illness
  • Substance abuse (narcotics)
  • Inability to provide consent
  • Osteomyelitis/discitis (spinal infection)
  • Spinal malignancy
  • Traumatic spinal injury

Surgical Approaches

TLIF - Transforaminal Lumbar Interbody Fusion
ALIF - Anterior Lumbar Interbody Fusion
LLIF - Lateral Lumbar Interbody Fusion

The choice of surgical approach will be individualized based on patient anatomy, pathology, and surgeon preference.