Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures

Lumbar Fracture Clinical Trial

— FRIFIX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01810094
• Other study ID #: AAG-O-H-0910
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: January 25, 2017
• Start date: February 2013
• Est. completion date: November 2016

Study information

• Verified date: January 2017
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2016
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Lumbar Fracture
• Thoracic Fracture

Intervention

Device:
• Fracture Fixation
Thoracolumbar Fracture Fixation

Locations

Country	Name	City	State
Germany	Vinzenz-Pallotti-Hospital	Bergisch Gladbach
Germany	Universitätsklinik Bonn, Abteilung für Unfallchirurgie	Bonn
Germany	Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln	Köln
Germany	Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen	Wermelskirchen

Sponsors (1)

Lead Sponsor	Collaborator
Aesculap AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior wedge angle (AWA)		6 weeks
Secondary	Blood loss of the patient during surgery to stabilize the spine fracture		intraoperative
Secondary	OP duration		intraoperative
Secondary	Adverse events		Intraop and Postop
Secondary	VAS Spine Score		3 days and 6 weeks
Secondary	VAS pain score		3 days and 6 weeks
Secondary	accompanying pain medication (or "self medication")		6 weeks
Secondary	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
Secondary	Hospital length of stay		discharge