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Dynamic Stabilization Versus Fusion (DYNORFUSE)

Primary Purpose

Degeneration of Lumbar Intervertebral Disc

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
standard
new
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degeneration of Lumbar Intervertebral Disc focused on measuring Lumbar degenerative disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prof. Dr. med. Bernhard Meyer

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

A

B

Arm Description

A - Fusion

B - Dynamic (new)

Outcomes

Primary Outcome Measures

Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention

Secondary Outcome Measures

Full Information

First Posted
June 1, 2011
Last Updated
September 11, 2018
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT01365754
Brief Title
Dynamic Stabilization Versus Fusion
Acronym
DYNORFUSE
Official Title
Posterior Dynamic Stabilization Versus Fusion in the Treatment of Lumbar Degenerative Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degeneration of Lumbar Intervertebral Disc
Keywords
Lumbar degenerative disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
A - Fusion
Arm Title
B
Arm Type
Active Comparator
Arm Description
B - Dynamic (new)
Intervention Type
Procedure
Intervention Name(s)
standard
Intervention Description
fusion
Intervention Type
Procedure
Intervention Name(s)
new
Intervention Description
dynamic stabilization
Primary Outcome Measure Information:
Title
Difference in Oswestry disability index (ODI) between treatment groups at 2 years post intervention
Time Frame
2 years after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Prof. Dr. med. Bernhard Meyer
City
München
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

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Dynamic Stabilization Versus Fusion

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