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.

• Conditions: M53.26; M43.16; M43.17; M43.06; M47.26

• Registration Number: DRKS00004514
• Lead Sponsor: eurochirurgische Universitätsklinik Freiburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-08
• Study Completion: 2016-11-25
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiation exposure of the surgeon, operating room staff and patient per monosegmental MIS TLIF in the FLUORO and NAV group (measured with dosimeters)

Secondary Outcome Measures

Name	Time	Method
- Radiation exposure of patients with bisegmental MIS TLIF in the FLUORO and NAV group<br>- Radiation exposure of the surgeon, operating room staff and patient depending on the body mass index (BMI) of patients in the FLUORO and NAV group<br>- Radiation exposure of the surgeon, operating room staff and patient per MIS TLIF with or without cement augmentation<br>- Clinical outcome (examination findings, questionnaires), fusion rate (follow-up, 12 months)<br>- Comparison of the accuracy of pedicle screws in the FLUORO and NAV group<br>- Comparison of the parameters of the sagittal balance (C7 plumb line, segmental / lumbar lordosis, pelvic tilt, sacral slope, pelvic incidence) between follow-up (12 months) and preoperatively in the FLUORO and NAV group in lateral X-rays