Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery (NCT03754972) | Clinical Trial Compass
CompletedNot Applicable
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
Netherlands100 participantsStarted 2019-02-20
Plain-language summary
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple treatment algorithm. The objective spinal stability metric is calculated from flexion-extension radiographs using previously validated methods.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Symptoms consistent with single level lumbar spinal stenosis based on judgment and experience of the investigator
✓. Central and or foraminal stenosis confirmed by MRI as per the investigators clinical standards
✓. Grades 1 (10 to 25%) or 2 (26 to 50%) anterior or retro-spondylolisthesis using the Meyerding scale \[43\]
✓. Absence of lateral spondylolisthesis
✓. No prior lumbar spinal surgery
✓. Absence of American Society of Anesthesiologists (ASA) class IV or higher disease
✓. 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)
✓. Prior to viewing the spinal motion report, the surgical plan includes decompression or decompression and fusion of only one level
Exclusion criteria
✕. Lumbar stenosis without spondylolisthesis
✕. 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 SPSI
✕. Pregnant women
✕
What they're measuring
1
Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning