Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures (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)

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Fracture; Lumbar Fracture
• Intervention / Treatment: Device: Fracture Fixation

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• Germany
  • Bergisch Gladbach, Germany, 51429
    • Vinzenz-Pallotti-Hospital
  • Bonn, Germany, 53127
    • Universitätsklinik Bonn, Abteilung für Unfallchirurgie
  • Köln, Germany, 50924
    • Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln
  • Wermelskirchen, Germany, 42929
    • Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

adult patients

Description

Inclusion Criteria:

• Minimum age of the patients of 18 years
• Indication for operative treatment of fractures of the thoracic or lumbar spine
• Singular A3.1-3 fractures according to the AO classification system
• Declaration of consent in participation in this study and willingness to the treatment according to the study protocol
• Physical and mental ability to meet the clinical and radiological follow-up plan

Exclusion Criteria:

• 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
• Other serious conditions complicating participation in the study
• Systemic or local infections
• Pregnancy or planned pregnancy
• Neurological deficits
• Severe blood coagulation disorders diagnosed preoperatively
• Intake of preoperatively anticoagulants
• Osteoporosis
• Bone metabolism disorders
• Laminectomy necessary during surgery results in exclusion of the patient either

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Minimally invasive Approach; Patients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach	Device: Fracture Fixation; Thoracolumbar Fracture Fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anterior wedge angle (AWA)	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood loss of the patient during surgery to stabilize the spine fracture		intraoperative
OP duration		intraoperative
Adverse events		Intraop and Postop
VAS Spine Score		3 days and 6 weeks
VAS pain score		3 days and 6 weeks
accompanying pain medication (or "self medication")		6 weeks
patient satisfaction with operational results	The patient is asked the question whether he is satisfied with the results of the operation, he has the choice between six answers: very satisfied, satisfied, partly satisfied, unsatisfied, no comment	6 weeks
Hospital length of stay		discharge

Collaborators and Investigators

• Sponsor: Aesculap AG
• Investigators: Principal Investigator: Hans Goost, MD, University Hospital, Bonn

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: February 26, 2013
• First Submitted That Met QC Criteria: March 12, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Estimate): January 26, 2017
• Last Update Submitted That Met QC Criteria: January 25, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: percutaneous; minimal invasive; fixation; thoracolumbar fracture; fixateur interne
• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: AAG-O-H-0910