Using SPECT/CT bone scans to identify candidates for lumbar surgery

Predictive Performance of SPECT/CT Bone Scan Quantification Before Lumbar Arthrodesis

This study is testing if a special type of bone scan can help doctors find out which patients with chronic low back pain are most likely to benefit from lumbar surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (Academic / other)
• Locations: 1 site (Vandœuvre-lès-Nancy)
• Trial ID: NCT05183542 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of SPECT/CT bone scan quantification to identify patients who are likely to respond positively to lumbar arthrodesis surgery for chronic low back pain. It aims to improve preoperative assessments by incorporating advanced imaging techniques to better predict surgical outcomes. Participants will undergo a bone scan prior to surgery, and their responses will be evaluated using the Oswestry Disability Index and Numerical Pain Scale. The goal is to enhance patient selection for surgery and ultimately improve recovery outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic low back pain lasting at least three months, likely due to degenerative disc disease or spondylolisthesis.

Not a fit: Patients with low back pain of neuropathic origin or those who have had previous lumbar spine surgeries may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective surgical interventions for patients with chronic low back pain, reducing unnecessary surgeries and improving quality of life.

How similar studies have performed: While the use of advanced imaging techniques in surgical candidate selection is gaining interest, this specific approach using SPECT/CT for lumbar arthrodesis is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

Inclusion Criteria:

* Persons with back pain for at least 3 months (presumed to be due to degenerative disc disease or spondylolisthesis).
* Persons who have received full information about the organisation of the research and have signed the informed consent and :

  * Age ≥ 18 years, having read and understood the information document.
  * Affiliated to a social security scheme.
* Lumbar arthrodesis involving a maximum of 2 floors.
* Standardized lumbar arthrodesis surgery performed by one of the three senior neurosurgeons of the neurosurgery department of the Nancy CHRU, using similar surgical techniques.

Exclusion Criteria:

* Low back pain of neuropathic origin. The Neuropathic Pain Scale 4 questionnaire is used to diagnose neuropathic pain (score is ≥ 4/10)
* History of lumbar spine surgery
* Presence of other pathologies responsible for lumbar pain (multistage discopathies, ankylosing spondylitis, spondylodiscitis, rheumatoid arthritis, vertebral compression, vertebral metastasis, narrow lumbar canal, scoliosis, spondylolisthesis by isthmic lysis)
* Pregnant women or women of childbearing age without suitable contraception or nursing mothers.
* Unstable medical condition and/or inability to remain immobile in supine position during recordings.
* Known allergy to any component of the radiopharmaceutical (TECHNESCAN HDP).
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code.
* Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care by virtue of Articles L. 3212-1 and L. 3213-1.
* Persons of full age who are unable to express their opposition.

Where this trial is running

Vandœuvre-lès-Nancy

• Nuclear Medicine Department — Vandœuvre-lès-Nancy, France (Recruiting)

Study contacts

• Study coordinator: Achraf BAHLOUL, MD

Conditions Pseudoarthrosis of Bone