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SPECT/CT Bone Scan Quantification Surgery

ConditionPseudoarthrosis of Bone
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Persons with back pain for at least 3 months (presumed to be due to degenerative disc disease or spondylolisthesis).

Age ≥ 18 years, having read and understood the information document.

Affiliated to a social security scheme.

Lumbar arthrodesis involving a maximum of 2 floors.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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)

Treatment groups

70 Participants
are divided into 1 treatment group
Group A: PatientsExperimental treatment 1 intervention

Trial outcomes

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

Time frame
24 months

Secondary outcomes

1

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

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 numeric scale (NS) measured at 12 months after surgery

Time frame
24 months
2

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

To determine whether SUVmax measured at early time on bone scans predicts a good response to lumbar spine fusion surgery according to the Oswestry Disability Index (ODI) measured at 12 months after surgery.

Time frame
24 months
3

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

To determine whether SUVmax measured at early time on bone scans predicts a good response to lumbar spine fusion surgery according to the Numeric Scale (NS) measured at 12 months after surgery.with Numeric Scale (NS)

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Central Hospital, Nancy, France

Lead sponsor

Source ClinicalTrials.gov
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