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Condition of Approval Study

NCT00517751 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2018-01-02

Study results available
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Summary

This prospective, multicenter longitudinal five-year study of X-STOP PEEK usage in LSS patients is designed to supplement pre-market safety and effectiveness data with information on longer-term device performance in a population of patients with moderately impaired physical function at preoperative baseline (i.e., an "indicated" population) who elect to undergo X STOP PEEK surgery.

Conditions

  • Lumbar Spinal Stenosis

Interventions

DEVICE

X-STOP PEEK

Placement of X-STOP PEEK in up to two levels in the lumbar spine for patients diagnosed with moderately symptomatic lumbar spinal stenosis in accordance with current labeling instructions for use.

Sponsors & Collaborators

  • Medtronic Spine LLC

    lead INDUSTRY

Principal Investigators

  • Jim Malcolm, MD · Pinnacle Orthopedics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2015-02-28
Completion
2015-04-30

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 NCT00517751 on ClinicalTrials.gov