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Comparison of Standard Fusion With "Topping Off"-System in Lumbar Spine

NCT01224379 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2010-10-20

No results posted yet for this study

Summary

Does a new "topping-off" device lead to a better clinical outcome compared to standard fusion? Does this device prevent the development of adjacent instability? Does radiological adjacent instability correlate with clinical outcome?

Conditions

  • Spondylolisthesis
  • Erosive Osteochondrosis in L2-S1

Interventions

DEVICE

Topping off system

The intervention group will receive a "topping off" system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion).

DEVICE

monosegmental PLIF

The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)

Sponsors & Collaborators

  • University of Cologne

    lead OTHER

Principal Investigators

  • Jan Siewe, Dr. · University of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2012-07-31
Completion
2012-10-31

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 NCT01224379 on ClinicalTrials.gov