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Clinical Trials/DRKS00004514
DRKS00004514
Completed
Not Applicable

Minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) using conventional fluoroscopy and 3D fluoroscopy-based navigation - a prospective, randomized comparative study regarding radiation exposure as well as radiological and clinical results.

eurochirurgische Universitätsklinik Freiburg0 sites50 target enrollmentNovember 8, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
M53.26
Sponsor
eurochirurgische Universitätsklinik Freiburg
Enrollment
50
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 8, 2012
End Date
November 25, 2016
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
eurochirurgische Universitätsklinik Freiburg

Eligibility Criteria

Inclusion Criteria

  • Full age to competent patients with planned mono\- or bisegmental MIS TLIF between LWK 2 and SWK 1 due to degeneration and / or instability including spondylolisthesis Meyerding grade I and II.
  • Both imaging techniques are considered suitable for MIS TLIF.
  • No improvement in symptoms for at least 3 months under conservative treatment.
  • Pain score (VAS for low back pain) of at least 3/10\.

Exclusion Criteria

  • Previous surgery in the affected or directly adjacent vertebral segment.
  • Spondylodiscitis, traumatic instability, osteoporotic vertebral fractures, neoplastic disease of the operating segment(s), spondylolisthesis Meyerding grade III and IV.
  • Indication for stabilization \> 2 segments.
  • One of the imaging techniques is not considered suitable for MIS TLIF.
  • Scoliosis with a Cobb angle \> 10 ° in the operating segment(s).

Outcomes

Primary Outcomes

Not specified

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