The Sagittal Plane Shear Index (SPSI) for planning whether to fuse after decompressing a stenotic lumbar level - SPSI for planning lumbar spinal stenosis surgery

Medical Metrics Diagnostics, Inc.0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年4月15日

试验速览

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•1. Symptoms consistent with single level lumbar spinal stenosis based on
•judgment and experience of the investigator
•2. Central and/ or foraminal stenosis confirmed by MRI as per the investigators
•clinical standards
•3. Grade 1 (10 to 25%) or 2 (26 to 50%) anterior or retro-spondylolisthesis
•using the Meyerding scale
•4. Absence of lateral spondylolisthesis
•5. No prior lumbar spinal surgery
•6. Absence of American Society of Anesthesiologists (ASA) class IV or higher
•7. The single level surgical technique planned (prior to viewing the spinal
•motion report) to decompress the level is not expected to destabilize the spine
•(fusion is not deemed necessary due to probable iatrogenic instability)
•8. Prior to viewing the spinal motion report, the surgical plan includes
•decompression or decompression and fusing of only one level
•9. Based on the investigators subjective assessment, the patient is able to
•flex and extend sufficiently to facilitate acceptable flexion and extension
•radiographs
•10. The fusion technique planned prior to viewing the spinal motion report is
•the following:
•Instrumented posterior (pedicle screws and rods) with / without PLIF cage
•11. Subject is able to understand and sign the study Informed Consent Form
•12. Subjects is at least 18 years of age.
•13. Subject has willingness and ability to comply with study procedures and
•visit schedules and able to follow oral and written instructions

•1. Lumbar stenosis without spondylolisthesis
•2. Severe lumbar stenosis that requires a wide decompression where the
•investigator believes (based on experience and available research studies) that
•the decompression will destabilize the spine and fusion surgery is required
•regardless of preoperative SPSITM
•3. Pregnant women
•4. Scoliosis involving a lumbar curve greater than 10 degrees
•5. Stenosis at the level of a transitional vertebra
•6. Lateral spondylolisthesis (Coronal plane translational misalignment
•between vertebrae)
•7. Prior lumbar spinal surgery
•8. American Society of Anesthesiologists (ASA) class IV or higher disease

发起方

Medical Metrics Diagnostics, Inc.