Pseudoarthrosis of Bone Clinical Trial
— PERQUALOfficial title:
Predictive Performance of SPECT/CT Bone Scan Quantification Before Lumbar Arthrodesis
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.
Status | Recruiting |
Enrollment | 70 |
Est. completion date | November 29, 2025 |
Est. primary completion date | April 29, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Nuclear Medicine Department | Vandoeuvre les Nancy cedex |
Lead Sponsor | Collaborator |
---|---|
Central Hospital, Nancy, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 24 months | |
Secondary | 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. | 24 months | |
Secondary | 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) | 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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