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SPECT/CT Bone Scan Quantification Surgery (PERQUAL)

Primary Purpose

Pseudoarthrosis of Bone

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bone scan
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pseudoarthrosis of Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nuclear Medicine DepartmentRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Patients with bone scan

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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)

Full Information

First Posted
December 21, 2021
Last Updated
March 28, 2023
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT05183542
Brief Title
SPECT/CT Bone Scan Quantification Surgery
Acronym
PERQUAL
Official Title
Predictive Performance of SPECT/CT Bone Scan Quantification Before Lumbar Arthrodesis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
April 29, 2024 (Anticipated)
Study Completion Date
November 29, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Chronic low back pain is a public health problem and is the leading cause of work stoppage and the management of low back pain refractory to medical treatment involves surgical procedures such as arthrodesis, aimed at fusing several adjacent vertebrae. The main gold standard tests for assessing the effectiveness of surgery are the Oswestry Disability Index (ODI), which takes into account the impact on quality of life and the numerical pain scale (EN). The ODI consists of 10 questions In order to compensate for the effect of analgesics on the ODI and EN scores, the response to both questionnaires should take into account the patient's symptomatology throughout the previous week. A decrease in the score of these 2 scales by at least the value of the MCID (Minimal Clinically Important Difference) is necessary to conclude a good response to surgery . The MCID value is 10% (0-100% score) for the Oswestry Disability Index (ODI) and 19 points (0-100 point scale) for the Numerical Pain Scale (EN) respectively. Standard diagnostic investigations performed during the preoperative workup for arthrodesis, mainly include X-rays, CT and lumbar MRI but not bone scans. None of the current standard preoperative examinations can identify a group of people without improvement after surgery. semiconductor cameras, allow bone scans with CT recordings coupled to a CT scan (SPECT/CT) offering better performance compared to a conventional camera . If abnormalities are detected, the binding intensity of the radiopharmaceutical is not only assessed visually but can also be quantified by the Standardized Uptake Value (SUV). To date, no preoperative examination that can predict the clinical evolution after lumbar arthrodesis has been reported apart from bone scintigraphy with visual assessment of fixation. Finding a threshold value for SUVmax to predict clinical outcome after surgery would potentially have an impact on the selection of "good responders" to lumbar spine arthrodesis, with other patients benefiting from medical treatment combined with rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pseudoarthrosis of Bone

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Patients with bone scan
Intervention Type
Drug
Intervention Name(s)
Bone scan
Other Intervention Name(s)
Scales of pain
Intervention Description
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)
Primary Outcome Measure Information:
Title
To determine if there is a correlation of SUV value and response to surgery with ODI
Description
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 Outcome Measure Information:
Title
To determine if there is a correlation of SUV value and response to surgery with NS
Description
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
Title
To determine if there is a correlation of SUV value at early time and response to surgery with ODI
Description
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
Title
To determine if there is a correlation of SUV value at early time and response to surgery with NS
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Achraf BAHLOUL, MD
Phone
383153911
Ext
+33
Email
a.bahloul@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Véronique ROCH, MSc
Phone
383154276
Ext
+33
Email
v.roch@chru-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
El Mehdi SIAGHY, PhD
Organizational Affiliation
CHRU Nancy
Official's Role
Study Director
Facility Information:
Facility Name
Nuclear Medicine Department
City
Vandoeuvre les Nancy cedex
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VERONIQUE ROCH, MSc
Phone
0383154276
Email
v.roch@chru-nancy.fr

12. IPD Sharing Statement

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SPECT/CT Bone Scan Quantification Surgery

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