Dynamic Stabilization Versus Fusion (DYNORFUSE)

September 11, 2018 updated by: Technical University of Munich

Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease

The purpose of this study is to compare posterior dynamic stabilization with fusion in the treatment of lumbar degenerative disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Two strategies for treatment of degenerative lumbar instability are in frequent clinical use: fusion versus dynamic stabilization. Up to now it is not clear whether fusion (Gold-standard) or the non-fusion technique is superior. Nevertheless some data are available that dynamic stabilization as a less invasive technique can achieve similar or better results concerning patient satisfaction and re-OP rate compared with fusion as the standard therapy.

Study Type

Interventional

Enrollment (Anticipated)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany, 81675
        • Prof. Dr. med. Bernhard Meyer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age >18 years
  • Mono- or bisegmental symptomatic lumbar degenerative disease with or without stenosis
  • Indication for fusion with (i) spondylolisthesis of at least 5mm or segmental vertebral motion of at least 3mm or 10º on flexion/extension radiographs, (ii) predominant low back pain in combination with Modic changes
  • Failure of adequate conservative measures for more than 3 months
  • Correctly signed informed consent form

Exclusion Criteria:

  • Olisthesis more than grade I, spondylolisthesis vera, spondylolysis without olisthesis or spinal deformity (i.e. scoliosis of more than 20°, sagittal imbalance)
  • Significant comorbidity impeding with surgical success (e.g. osteoporosis, rheumatoid arthritis, mental illness)
  • Previous fusion or stabilization surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
A - Fusion
Procedure: standard
fusion
ACTIVE_COMPARATOR: B
B - Dynamic (new)
Procedure: new
dynamic stabilization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
Time Frame: 2 years after intervention
2 years after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

August 1, 2018

Study Registration Dates

First Submitted

June 1, 2011

First Submitted That Met QC Criteria

June 2, 2011

First Posted (ESTIMATE)

June 3, 2011

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYN-1009-MEY-0000-I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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