Lumbar Stenosis narrowing of the lumbar spinal canal
Conditions
Interventions
Flexion- and extension radiographs are performed at the hospital, and will be
send to Sponsor for calculation of the SPSI. Based on the SPSI, the surgeon
will adjust the surgical plan as required. T
Sponsors
Medical Metrics Diagnostics, Inc.
Eligibility
Age
18 Years to 99 Years
Inclusion 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. 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of lumbar spinal stenosis treatment plans that change when SPSI results are used in establishing the surgical plan. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of clinical outcomes in lumbar stenosis patients where surgical planning included SPSI, compared to historical controls This will include comparison of the SPSITM pre-surgically and 12-month post-surgically, comparison of ODI and NRS-LP questionnaires pre-surgically, at 12-months and 24-months post-surgically. | — |
Countries
Netherlands
Outcome results
None listed