NCT01810094

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2013

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

February 26, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

February 26, 2013

Last Update Submit

January 25, 2017

Conditions

Thoracic FractureLumbar Fracture

Keywords

thoracolumbar fracturefixationfixateur interneminimal invasivepercutaneous

Outcome Measures

Primary Outcomes (1)

  • Anterior wedge angle (AWA)

    6 weeks

Secondary Outcomes (8)

  • Blood loss of the patient during surgery to stabilize the spine fracture

    intraoperative

  • OP duration

    intraoperative

  • Adverse events

    Intraop and Postop

  • VAS Spine Score

    3 days and 6 weeks

  • VAS pain score

    3 days and 6 weeks

  • +3 more secondary outcomes

Study Arms (1)

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

Interventions

Fracture FixationDEVICE

Thoracolumbar Fracture Fixation

Minimally invasive Approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Vinzenz-Pallotti-Hospital

Bergisch Gladbach, 51429, Germany

Location

Universitätsklinik Bonn, Abteilung für Unfallchirurgie

Bonn, 53127, Germany

Location

Klinik für Unfall-, Hand- und Wiederherstellungschirurgie, Universitätsklinik Köln

Cologne, 50924, Germany

Location

Abteilung für Orthopädie und Unfallchirurgie, Krankenhaus Wermelskirchen

Wermelskirchen, 42929, Germany

Location

MeSH Terms

Conditions

Fractures, Bone

Interventions

Fracture Fixation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsSurgical Procedures, Operative

Study Officials

  • Hans Goost, MD

    University Hospital, Bonn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2013

First Posted

March 13, 2013

Study Start

February 1, 2013

Primary Completion

October 1, 2014

Study Completion

November 1, 2016

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

DE(4)