Clinical trial NCT01810094: Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Fracture
Lumbar Fracture
Keywords: thoracolumbar fracture
fixation
fixateur interne
minimal invasive
percutaneous
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2013-03-13
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients

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.


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

Primary outcomes:
measure: Anterior wedge angle (AWA)
timeFrame: 6 weeks
Secondary outcomes:
measure: Blood loss of the patient during surgery to stabilize the spine fracture
timeFrame: intraoperative
measure: OP duration
timeFrame: intraoperative
measure: Adverse events
timeFrame: Intraop and Postop
measure: VAS Spine Score
timeFrame: 3 days and 6 weeks
measure: VAS pain score
timeFrame: 3 days and 6 weeks
measure: accompanying pain medication (or "self medication")
timeFrame: 6 weeks
measure: patient satisfaction with operational results
timeFrame: 6 weeks
measure: Hospital length of stay
timeFrame: discharge
Other outcomes:
Locations:
city: Bergisch Gladbach
country: Germany
facility: Vinzenz-Pallotti-Hospital
city: Bonn
country: Germany
facility: Universitätsklinik Bonn, Abteilung für Unfallchirurgie
city: Köln
country: Germany
facility: Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln
city: Wermelskirchen
country: Germany
facility: Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen
Study officials:
affiliation: University Hospital, Bonn
name: Hans Goost, MD
role: PRINCIPAL_INVESTIGATOR
References: