NCT01810094

Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures

Prospective Observational Study of Minimally Invasive Fixation of Thoracolumbar Fractures With the Fracture Fixation System S4, Performed With the Fracture Reduction Instrumentation FRI (FRIFIX)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits. Depending on the type of injury there are various methods available to stabilize the spine. The proposed study should clarify whether the combined reduction and fixation with a minimally invasive approach can actually be done with the same precision as in a conventional approach. The primary endpoint of this investigation is the monosegmental anterior wedge angle (AWA), and its maintenance over the first 6 postoperative weeks. It is the aim of the study to gather key radiological, clinical and subjective patient outcome parameters for its patient population that will allow to compare the results to a historical group of patients. The study design is non-interventional, prospective, open,and multicentric.

Conditions

• Thoracic Fracture
• Lumbar Fracture

Interventions

Type	Name	Description
DEVICE	Fracture Fixation	Thoracolumbar Fracture Fixation

Timeline

• Start date: 2013-02-01
• Primary completion: 2014-10-01
• Completion: 2016-11-01
• First posted: 2013-03-13
• Last updated: 2017-01-26

Locations

4 sites across 1 country: Germany