Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures (FRIFIX)

Aesculap

Status: Completed

Conditions: Thoracic Fracture; Lumbar Fracture

Treatments: Device: Fracture Fixation

Study type: Observational

Funder types: Industry

Identifiers

NCT01810094

AAG-O-H-0910

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

24 participants in 1 patient group

Minimally invasive Approach

Description:

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

Treatment:

Device: Fracture Fixation