SuspendedNot Applicable

Pedicle Osteotomy for Stenosis Trial

Stopped: In light of the ongoing COVID-19 pandemic and its impact on clinical trials

United States344 participantsStarted 2017-10-26

Plain-language summary

This is a pivotal Randomized Clinical trial to compare the safety and effectiveness of the Pedicle Lengthening Osteotomy Procedure with implantation of the Altum® Device to open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) in patients with symptomatic, one or two level lumbar spinal stenosis (LSS) and one level grade I degenerative spondylolisthesis requiring surgical treatment.

Who can participate

Age range

40 Years – 80 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

. Is a male or female patient between 40 and 80 years of age.
. Has the diagnosis of degenerative spinal stenosis of the lumbar region (defined as L2-L5), defined by one or more of the following: a) narrowingof the mid-sagittal spinal canal (central stenosis), b) narrowing between the facet superior articular process (SAP) and the posterior intervertebral disc margin (lateral recess stenosis), c) narrowing of the nerve root foraminal canal(s) (foraminal stenosis) and has, at the same level, radiographic confirmation on plain lateral flexion/extension radiographs of a degenerative grade I spondylolisthesis at the same level, defined as at least 1% but not greater than 25%, offset between the posterior margins of the adjacent vertebral bodies at the index level.
. Neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain, which is worse with extended posture and relieved by flexion, as evidenced by patient history.
. Has pain in the leg and/or buttock that is worse with standing as compared to sitting.

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

Zurich Claudication Questionnaire (ZCQ)

Timeframe: 24 months

No reoperations

Timeframe: Index level

Adjacent level surgery

Timeframe: 24 months

Adverse events

Timeframe: 24 months

Radiological Success

Timeframe: 24 months

Trial details

NCT IDNCT03381677

SponsorInnovative Surgical Designs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-10-26

View on ClinicalTrials.gov More Lumbar Spinal Stenosis trials

Plain-language summary

Who can participate

Age range

40 Years – 80 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

. Is a male or female patient between 40 and 80 years of age.
. Has the diagnosis of degenerative spinal stenosis of the lumbar region (defined as L2-L5), defined by one or more of the following: a) narrowingof the mid-sagittal spinal canal (central stenosis), b) narrowing between the facet superior articular process (SAP) and the posterior intervertebral disc margin (lateral recess stenosis), c) narrowing of the nerve root foraminal canal(s) (foraminal stenosis) and has, at the same level, radiographic confirmation on plain lateral flexion/extension radiographs of a degenerative grade I spondylolisthesis at the same level, defined as at least 1% but not greater than 25%, offset between the posterior margins of the adjacent vertebral bodies at the index level.
. Neurogenic claudication or radiculopathic symptoms including leg pain, muscle weakness, and/or sensation abnormality, with or without back pain, which is worse with extended posture and relieved by flexion, as evidenced by patient history.
. Has pain in the leg and/or buttock that is worse with standing as compared to sitting.

Pedicle Osteotomy for Stenosis Trial

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Pedicle Osteotomy for Stenosis Trial

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