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Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures (FRIFIX)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Aesculap AG
ClinicalTrials.gov Identifier:
NCT01810094
First received: February 26, 2013
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Thoracic Fracture
Lumbar Fracture
Device: Fracture Fixation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Aesculap AG:

Primary Outcome Measures:
  • Anterior wedge angle (AWA) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood loss of the patient during surgery to stabilize the spine fracture [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • OP duration [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: Intraop and Postop ] [ Designated as safety issue: No ]
  • VAS Spine Score [ Time Frame: 3 days and 6 weeks ] [ Designated as safety issue: No ]
  • VAS pain score [ Time Frame: 3 days and 6 weeks ] [ Designated as safety issue: No ]
  • accompanying pain medication (or "self medication") [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • patient satisfaction with operational results [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: discharge ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2013
Estimated Study Completion Date: April 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Minimally invasive Approach
Patients with a thoracolumbar Fracture A3.1 to A 3.3 treated by fracture fixation by a minimally invasive approach
Device: Fracture Fixation
Thoracolumbar Fracture Fixation
Other Name: Fracture Fixation

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01810094

Locations
Germany
Vinzenz-Pallotti-Hospital
Bergisch Gladbach, Germany, 51429
Universitätsklinik Bonn, Abteilung für Unfallchirurgie
Bonn, Germany, 53127
Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln
Köln, Germany, 50924
Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen
Wermelskirchen, Germany, 42929
Sponsors and Collaborators
Aesculap AG
Investigators
Principal Investigator: Hans Goost, MD Universitätsklinikum Bonn
  More Information

No publications provided

Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT01810094     History of Changes
Other Study ID Numbers: AAG-O-H-0910
Study First Received: February 26, 2013
Last Updated: October 21, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Aesculap AG:
thoracolumbar fracture
fixation
fixateur interne
minimal invasive
percutaneous

Additional relevant MeSH terms:
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on November 27, 2014