NCT01365754

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2011

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 12, 2018

Status Verified

September 1, 2018

Enrollment Period

6.3 years

First QC Date

June 1, 2011

Last Update Submit

September 11, 2018

Conditions

Degeneration of Lumbar Intervertebral Disc

Keywords

Lumbar degenerative disease

Outcome Measures

Primary Outcomes (1)

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

    2 years after intervention

Study Arms (2)

A

ACTIVE COMPARATOR

A - Fusion

Procedure: standard

B

ACTIVE COMPARATOR

B - Dynamic (new)

Procedure: new

Interventions

standardPROCEDURE

fusion

A
newPROCEDURE

dynamic stabilization

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. med. Bernhard Meyer

München, 81675, Germany

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2011

First Posted

June 3, 2011

Study Start

September 1, 2011

Primary Completion

December 1, 2017

Study Completion

August 1, 2018

Last Updated

September 12, 2018

Record last verified: 2018-09

Locations

DE(1)