avigation-guided and 3D-imaging controlled minimally invasive posterior instrumentation in patients with pyogenic thoracolumbar spondylodiscitis

Not Applicable

Recruiting

• Conditions: M46.4; Discitis, unspecified

• Registration Number: DRKS00010843
• Lead Sponsor: eurochirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-15
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

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

Inclusion Criteria

Subjects with the indication for operative treatment of pyogenic thoracolumbar spondylodiscitis (minimally invasive posterior instrumentation +/- decompression +/- vertebral body biopsy; navigation-guidance/3D-imaging).

Exclusion Criteria

•Patient not suitable for anaesthesia
•Treatment with any other (surgical or conservative) procedure
•Incomplete data
•No study consent

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Difference (vs. preoperative) Oswestry Disability Index (ODI) at 6 months<br>

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints: Pain and disability postoperative, at 6 weeks, 6 months, and 12 months (ODI; Visual Analogue Scale/ VAS; Macnab criteria), quality of life (EQ-5D-3L), time to mobilization, laboratory values (leukocytes, CRP), screw misplacement (Gertzbein/ Robbins), intra-/perioperative complications, reoperations, sagittal profile angles, formation of bridging bony spurs.