FRIFIXProspective Observational Study of Minimally Invasive Fixation of Thoracolumbar Fractures With the Fracture Fixation System S4, Performed With the Fracture Reduction Instrumentation FRI (FRIFIX)
Device Data
Collected from today forward - ProspectiveWounds and Injuries
+ Fractures, Bone
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: February 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Universitätsklinik Bonn, Abteilung für Unfallchirurgie
Bonn, GermanyKlinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln
Cologne, GermanyAbteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen
Wermelskirchen, Germany