Clinical trial NCT03754972: Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
Official title: The Sagittal Plane Shear Index (SPSI) for Planning Whether to Fuse After Decompressing a Stenotic Lumbar Level
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Spinal Stenosis
Spondylolisthesis
Keywords: lumbar
spondylolisthesis
instability
diagnosis
treatment planning
fusion
decompression
Lead sponsor: Medical Metrics Diagnostics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Avania
First posted: 2018-11-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Determine whether an objective metric for spinal stability will change the surgical treatment plan in a significant proportion of patients with lumbar spinal stenosis
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Patients with previously diagnosed lumbar spinal stenosis and spondylolisthesis, who have consented to surgical treatment consisting of either decompression alone or decompression plus fusion will be invited to participate in the study. The initial surgical plan will be recorded prior to reviewing the sagittal plane shear index (SPSI). The sagittal plane shear index will be calculated flexion-extension radiographs. The measurements required to calculate SPSI will be obtained using previously validated methods. SPSI greater than 2 indicates that the translation-per-degree of rotation (TPDR) is above the upper limit of the 95% confidence interval observed in several hundred asymptomatic and radiographically normal individuals. SPSI will be reported to the surgeon after recording the pre-SPSI surgical plan. The surgeon will then decide whether to change the surgical plan. For example, if the initial surgical plan was to only decompress a level, and SPSI is greater than 2, the surgeon may plan to add fusion to the decompression. Conversely, if the initial plan was decompression plus fusion, and the SPSI indicates that the level is objectively stable, the post-SPSI plan may be to only decompress the level. The proportion of surgical plans that change after reviewing the SPSI report will be determined. If the proportion of surgical plans that change is greater than 15%, further research will be undertaken to explore whether deciding, based on objective measurement of spinal stability, whether to add fusion to decompression of a stenotic lumbar level will have a significant effect on clinical outcomes.

Eligibility criteria: Inclusion Criteria:

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. Grades 1 (10 to 25%) or 2 (26 to 50%) anterior or retro-spondylolisthesis using the Meyerding scale \[43\]
4. Absence of lateral spondylolisthesis
5. No prior lumbar spinal surgery
6. Absence of American Society of Anesthesiologists (ASA) class IV or higher disease
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 fusion 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 postero-lateral interbody fusion 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

Exclusion Criteria:

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 SPSI
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

Primary outcomes:
measure: Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning
timeFrame: Pre-surgery
Secondary outcomes:
measure: Association Between the Preoperative SPSI and the Facet Fluid Sign Observed in a Preoperative MRI
timeFrame: Pre-surgery
measure: The Proportion of Surgically Decompressed Levels Where SPSI Was at Least One Standard Deviation Higher at 12 Months Compared to Preoperatively.
timeFrame: One year after surgery
measure: Reoperation Rate at 1 and 2 Years Following Surgery
timeFrame: 12 and 24 months
measure: 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.
timeFrame: 12 months
measure: 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
timeFrame: 12 months
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG Oost
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Medical Metrics Diagnostics, Inc
name: John Hipp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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