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Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®

NCT00534092 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 69

Last updated 2021-01-05

Study results available
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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.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DEVICE

X STOP® Interspinous Process Decompression System

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.

Sponsors & Collaborators

  • Medtronic Spine LLC

    lead INDUSTRY

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00534092 on ClinicalTrials.gov