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Completed

NCT Number: NCT01810094

Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures

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.

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Key information

Conditions

Thoracic Fracture Fractures, Bone Lumbar Fracture Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vinzenz-Pallotti-Hospital, Bergisch Gladbach, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fracture Fixation

Device

Thoracolumbar Fracture Fixation

Primary outcomes

  1. Anterior wedge angle (AWA)

    Time frame: 6 weeks

Secondary outcomes

  1. Blood loss of the patient during surgery to stabilize the spine fracture

    Time frame: intraoperative

  2. OP duration

    Time frame: intraoperative

  3. Adverse events

    Time frame: Intraop and Postop

  4. VAS Spine Score

    Time frame: 3 days and 6 weeks

  5. VAS pain score

    Time frame: 3 days and 6 weeks

  6. accompanying pain medication (or "self medication")

    Time frame: 6 weeks

  7. patient satisfaction with operational results

    Time frame: 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

  8. Hospital length of stay

    Time frame: discharge

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Registry information

Official study 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)

Acronym: FRIFIX

Important dates

Study start
2013
Primary completion
2014
Study completion
2016
First posted
Mar 13, 2013
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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