SPECT/CT Bone Scan Quantification Surgery

NCT05183542 | Recruiting

• 1 other identifier: 2021PI050
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The hypothesis of our study is that SPECT/CT bone scan fixation quantified by SUVMAX on a CZT solid state camera preoperatively would identify good responders to lumbar arthrodesis surgery.

Conditions

Pseudoarthrosis of Bone

Outcome Measures

Primary Outcomes (1)

• To determine if there is a correlation of SUV value and response to surgery with ODI

  To determine whether SUVmax (Standard Uptake Value) measured at late time on bone scan, predicts a good response to lumbar arthrodesis surgery according to the Oswestry Disability Index (ODI) measured at 12 months after surgery

  24 months

Secondary Outcomes (3)

• To determine if there is a correlation of SUV value and response to surgery with NS

  24 months

• To determine if there is a correlation of SUV value at early time and response to surgery with ODI

  24 months

• To determine if there is a correlation of SUV value at early time and response to surgery with NS

  24 months

Study Arms (1)

Patients

EXPERIMENTAL

Patients with bone scan

Drug: Bone scan

Interventions

Bone scan DRUG

Persons to be operated on for lumbar arthrodesis by the neurosurgery team of the Nancy CHRU and respecting the eligibility criteria (including a score of neuropathique pain scale \< 4, see non-inclusion criteria), will be proposed to participate in the study neuropathic pain If they give their oral agreement to the neurosurgeon, a request for a bone scan will be sent to the nuclear medicine department of the Nancy-Brabois Hospital. The patients will fill pain scales before and after surgery (ODI and NS)

Also known as: Scales of pain

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Nuclear Medicine Department

Vandœuvre-lès-Nancy, 54511, France

RECRUITING

Study Officials

• El Mehdi SIAGHY, PhD

  CHRU Nancy

  STUDY DIRECTOR

Central Study Contacts

Achraf BAHLOUL, MD

CONTACT

383153911; a.bahloul@chru-nancy.fr

Véronique ROCH, MSc

CONTACT

383154276; v.roch@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Persons to be operated on for lumbar arthrodesis by the neurosurgery team of the Nancy CHRU and respecting the eligibility criteria (including neuropathic pain scale score \< 4, see non-inclusion criteria), will be proposed to participate in the study

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 10, 2022
• Study Start: April 29, 2022
• Primary Completion: November 29, 2025
• Study Completion: November 29, 2025
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

FR (1)