Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures

NCT ID: NCT01810094

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-11-30

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.

Conditions

Thoracic Fracture; Lumbar Fracture

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Minimally invasive Approach

Patients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach

Fracture Fixation

Intervention Type: DEVICE

Thoracolumbar Fracture Fixation

Interventions

Fracture Fixation

Thoracolumbar Fracture Fixation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aesculap AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Goost, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bonn

Locations

Vinzenz-Pallotti-Hospital

Bergisch Gladbach, , Germany

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

Countries

Germany

Other Identifiers

AAG-O-H-0910

Identifier Type: -

Identifier Source: org_study_id