N/A
N=100
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
Lumbar Spinal Stenosis · Spondylolisthesis
Bottom Line
View on ClinicalTrials.gov: NCT03754972 ↗Enrolled (actual)
100
Serious AEs
34.7%
Results posted
Jul 2024
Primary outcome: Primary: Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning — 47; 22; 6 Surgical plans
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sagittal plane shear index (SPSI) (Diagnostic_test)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical Metrics Diagnostics, Inc
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning |
47; 22; 6 | — |
| SECONDARY Association Between the Preoperative SPSI and the Facet Fluid Sign Observed in a Preoperative MRI |
— | — |
| SECONDARY The Proportion of Surgically Decompressed Levels Where SPSI Was at Least One Standard Deviation Higher at 12 Months Compared to Preoperatively. |
— | — |
| SECONDARY Reoperation Rate at 1 and 2 Years Following Surgery |
— | — |
| SECONDARY Are the ODI Scores at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union. |
— | — |
| SECONDARY Is Leg Pain at 12 Months Following Lumbar Fusion Surgery Dependent on Whether the Treated Level is Fused, With Fusion Defined as Intervertebral Rotation < 2 Degrees and an Absence of Radiographic Signs of a Non-union |
— | — |
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.
Eligibility Criteria
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
- Based on the investigators subjective assessment, the patient is able to flex and extend sufficiently to facilitate acceptable flexion and extension radiographs
- The fusion technique planned prior to viewing the spinal motion report is the following: Instrumented posterior (pedicle screws and rods) with / without postero-lateral interbody fusion cage
- Subject is able to understand and sign the study Informed Consent Form
- Subjects is at least 18 years of age.
- Subject has willingness and ability to comply with study procedures and visit schedules and able to follow oral and written instructions
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
- Scoliosis involving a lumbar curve greater than 10 degrees
- Stenosis at the level of a transitional vertebra
- Lateral spondylolisthesis (Coronal plane translational misalignment between vertebrae)
- Prior lumbar spinal surgery
- American Society of Anesthesiologists (ASA) class IV or higher disease
Data sourced from ClinicalTrials.gov (NCT03754972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.