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

Recruiting

• Conditions: Lumbar Stenosis; narrowing of the lumbar spinal canal; 10009720

• Registration Number: NL-OMON56061
• Lead Sponsor: Medical Metrics Diagnostics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

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. 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
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 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

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 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of lumbar spinal stenosis treatment<br /><br>plans that change when SPSI results are used in establishing the surgical plan.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Comparison of clinical outcomes in lumbar stenosis patients where surgical<br /><br>planning included SPSI, compared to historical controls<br /><br>This will include comparison of the SPSITM pre-surgically and 12-month<br /><br>post-surgically, comparison of ODI and NRS-LP questionnaires pre-surgically, at<br /><br>12-months and 24-months post-surgically.</p><br>