Status:
COMPLETED
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
Lead Sponsor:
Medical Metrics Diagnostics, Inc
Collaborating Sponsors:
Avania
Conditions:
Lumbar Spinal Stenosis
Spondylolisthesis
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03754972
Start Date
February 20 2019
End Date
March 1 2025
Last Update
May 29 2025
Active Locations (3)
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1
OLVG Oost
Amsterdam, Netherlands
2
Rijnstate Hospital
Arnhem, Netherlands
3
Isala
Zwolle, Netherlands