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Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis

NCT00405691 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2011-05-18

No results posted yet for this study

Summary

The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal claudication, that results from moderate or severe lumbar spinal stenosis at one vertebral level between L3 and L5.

Conditions

  • Low Back Pain
  • Leg Pain
  • Spondylolisthesis
  • Lumbar Spinal Stenosis

Interventions

DEVICE

"TOPS System" - Total Posterior Arthroplasty Implant

Sponsors & Collaborators

  • Impliant, Ltd.

    lead INDUSTRY

Principal Investigators

  • Paul McAfee, M.D. · Orthopaedic Associates, P.A

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-09-30

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 NCT00405691 on ClinicalTrials.gov