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Wallis Mechanical Normalization System for Low Back Pain

NCT00134537 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2011-10-04

No results posted yet for this study

Summary

The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.

Conditions

  • Low Back Pain

Interventions

DEVICE

Interspinous process and dynamic stabilization

Interspinous process and dynamic stabilization

DEVICE

Conservative Care

Medication, exercise and spinal injections

Sponsors & Collaborators

  • Zimmer Biomet

    collaborator INDUSTRY

  • Zimmer Spine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Primary Completion
2011-04-30
Completion
2012-04-30

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 NCT00134537 on ClinicalTrials.gov