CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 69 enrolled
Drug / intervention
X STOP® Interspinous Process Decompression Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00534092
NCT00534092N/ACompleted
CompareCT.gov

Long-term Outcomes Among Patients With Lumbar Spinal Stenosis Treated With the X STOP® Interspinous Process Decompression System: Five-Year Follow-up of IDE Patient Cohorts

Medtronic Spine LLC·observational·Posted Sep 24, 2007·Updated Jan 5, 2021

In Brief

An observational study evaluating X STOP® Interspinous Process Decompression System for Lumbar Spinal Stenosis. Completed, enrolled 69 participants across 5 sites.

Detailed Summary

The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsLumbar Spinal Stenosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2007
Enrollment StartDec 1, 2006
Study CompletionJun 1, 2010
TodayJul 2, 2026
Posted 18.8 years ago

Interventions

X STOP® Interspinous Process Decompression Systemdevice

The X STOP is a titanium implant that fits between the spinous processes of the lumbar spine. It is made from Ti-6AI-4V Eli titanium alloy (ISO 5832/3) and consists of two components: a spacer assembly and a wing assembly.