CompletedNot Applicable

Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

Netherlands100 participantsStarted 2019-02-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Surgical Plans Recorded Prior to the SPSI Report That Are Altered After Integration of SPSI Into the Surgical Planning

Timeframe: Pre-surgery

Trial details

NCT IDNCT03754972

SponsorMedical Metrics Diagnostics, Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-01

Results submitted2024-02-19

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria