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A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine

NCT01143324 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 255

Last updated 2019-01-08

Study results available
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Summary

The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF (Transforaminal Lumbar Interbody Fusion) techniques for the treatment of the degenerative lumbar spine in a "real-world" patient population.

Conditions

  • Degenerative Lumbar Spine Causing Back and/or Leg Pain
  • Lumbar Spine Degeneration

Interventions

DEVICE

MAST™ procedure

Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.

Sponsors & Collaborators

  • Medtronic Spinal and Biologics

    lead INDUSTRY

Principal Investigators

  • Jörg Franke, PD Dr. · Klinik für Wirbelsäulenchirurgie; Dortmund

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-05-31
Completion
2013-08-31

Countries

  • Austria
  • Belgium
  • Canada
  • Czechia
  • Germany
  • Greece
  • Israel
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Slovakia
  • Spain
  • United Kingdom

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 NCT01143324 on ClinicalTrials.gov