Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Device Data

Collected from today forward - Prospective
Device
Who is being recruted

Wounds and Injuries

+ Fractures, Bone

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: February 2013
See protocol details

Summary

Principal SponsorAesculap AG
Last updated: January 26, 2017
Sourced from a government-validated database.Claim as a partner

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.

Principal SponsorAesculap AG
Last updated: January 26, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Wounds and InjuriesFractures, Bone

Criteria

5 inclusion criteria required to participate
Declaration of consent in participation in this study and willingness to the treatment according to the study protocol

Indication for operative treatment of fractures of the thoracic or lumbar spine

Minimum age of the patients of 18 years

Physical and mental ability to meet the clinical and radiological follow-up plan

Show More Criteria

11 exclusion criteria prevent from participating
Additional severe trauma, that makes survey of the patient difficult or impossible influence the results of the fracture treatment significantly

Additional trauma or fractures of the spine

Bone metabolism disorders

Intake of preoperatively anticoagulants

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

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

Vinzenz-Pallotti-Hospital

Bergisch Gladbach, GermanyOpen Vinzenz-Pallotti-Hospital in Google Maps

Universitätsklinik Bonn, Abteilung für Unfallchirurgie

Bonn, Germany

Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln

Cologne, Germany

Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen

Wermelskirchen, Germany
Completed4 Study Centers
FRIFIX | Prospective Observational Study of Minimally Invasive Fixation of Thoracolumbar Fractures With the Fracture Fixation System S4, Performed With the Fracture Reduction Instrumentation FRI (FRIFIX) | PatLynk