Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures

Completed

• Conditions: Thoracic Fracture; Lumbar Fracture
• Interventions: Device: Fracture Fixation

• Registration Number: NCT01810094
• Lead Sponsor: Aesculap AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-03-12
• Study First Posted: 2013-03-13
• Primary Completion: 2014-10
• Study Completion: 2016-11
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimally invasive Approach	Fracture Fixation	Patients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach

Primary Outcome Measures

Name	Time	Method
Anterior wedge angle (AWA)	6 weeks

Secondary Outcome Measures

Name	Time	Method
accompanying pain medication (or "self medication")	6 weeks
Blood loss of the patient during surgery to stabilize the spine fracture	intraoperative
OP duration	intraoperative
patient satisfaction with operational results	6 weeks	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
Hospital length of stay	discharge
Adverse events	Intraop and Postop
VAS Spine Score	3 days and 6 weeks
VAS pain score	3 days and 6 weeks

Trial Locations

Locations (4)

Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln; 🇩🇪 Köln, Germany

Universitätsklinik Bonn, Abteilung für Unfallchirurgie; 🇩🇪 Bonn, Germany

Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen; 🇩🇪 Wermelskirchen, Germany

Vinzenz-Pallotti-Hospital; 🇩🇪 Bergisch Gladbach, Germany