Dynamic Stabilization Versus Fusion

NCT ID: NCT01365754

Last Updated: 2018-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2018-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Degeneration of Lumbar Intervertebral Disc

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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A

A - Fusion

Group Type ACTIVE_COMPARATOR

standard

Intervention Type PROCEDURE

fusion

B

B - Dynamic (new)

Group Type ACTIVE_COMPARATOR

new

Intervention Type PROCEDURE

dynamic stabilization

Interventions

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standard

fusion

Intervention Type PROCEDURE

new

dynamic stabilization

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Prof. Dr. med. Bernhard Meyer

München, , Germany

Site Status

Countries

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Germany

Other Identifiers

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DYN-1009-MEY-0000-I

Identifier Type: -

Identifier Source: org_study_id

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