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Clinical Trial Comparing Decompression With and Without Coflex™ Interlaminar Technology Treating Lumbar Spinal Stenosis

NCT01316211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2020-06-09

Study results available
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Summary

A 2 year comparative evaluation of clinical outcome in the treatment of degenerative spinal stenosis with concomitant low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology

Conditions

  • Spinal Stenosis

Interventions

DEVICE

Implantation of coflex™ after surgical decompression

The device will be implanted after surgical decompression in patients with spinal stenosis.

PROCEDURE

Surgical decompression

Surgical decompression in patients with spinal stenosis without stabilization by an additional implant

Sponsors & Collaborators

  • MDT Medical Device Testing GmbH

    collaborator INDUSTRY

  • MCRA

    collaborator INDUSTRY

  • Paradigm Spine

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • Germany

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 NCT01316211 on ClinicalTrials.gov