NCT01126385

Brief Summary

A new mechanical device was developed in order to provide the surgeon with intraoperative information about the mechanical strength of the cancellous bone within the vertebral body. DensiProbe Spine is intended to be used in patients undergoing transpedicular stabilization of the thoracolumbar spine. The objective of the DensiProbe Spine pilot study is to investigate the handling and feasibility of the DensiProbe Spine measurement device.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

2 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

First Submitted

Initial submission to the registry

May 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

January 25, 2013

Status Verified

January 1, 2013

Enrollment Period

1.6 years

First QC Date

May 18, 2010

Last Update Submit

January 24, 2013

Conditions

Spinal Diseases

Keywords

Spinal DiseasesBone strengthTranspedicular fixationDorsal instrumentationDensiProbe

Outcome Measures

Primary Outcomes (2)

  • Surgeon's compliance- and handling-oriented questionnaire

    The general satisfaction of the surgeon with DensiProbe Spine as well as specific problems that are likely to occur during the measurement with DensiProbe Spine will be assessed

    Baseline

  • Intra- and post-operative adverse events

    All intra- and postoperative adverse events will be assessed and analyzed regarding their relationship to the study device

    Up to 2 months postsurgery

Secondary Outcomes (4)

  • Bone mineral density

    Baseline

  • Pedicle screw migration

    2 months postsurgery

  • QCT analysis of bone biopsies

    Baseline

  • Application of bone cement

    Baseline

Study Arms (1)

Transpedicular stabilization

Patients undergoing transpedicular stabilization of the spine

Device: DensiProbe Spine

Interventions

DensiProbe SpineDEVICE

Intraoperative DensiProbe Spine measurements

Transpedicular stabilization

Eligibility Criteria

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

Patients undergoing transpedicular stabilization of the spine

You may qualify if:

  • Age 18 or older
  • Indication for transpedicular fixation of the thoracolumbar spine
  • Ability to understand and read local language at an elementary level
  • Signed informed consent by patient or legal guardian to participate in the study according to the protocol

You may not qualify if:

  • Patients who are legally incompetent
  • Scoliosis (Cobb angle on AP radiograph \> 10°)
  • Benign or malign vertebral bone tumour
  • Active malignancy
  • Infection diseases, eg. hepatitis, human immunodeficiency virus (HIV)
  • Pre-drilling with power-drill
  • Life-threatening condition
  • Drug or alcohol abuse
  • Participation in any other medical device or drug study that could influence the results of the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Klinik Sonnenhof

Bern, Canton of Bern, 3006, Switzerland

Location

Inselspital

Bern, Canton of Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • Lorin M Benneker, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 19, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2012

Study Completion

August 1, 2012

Last Updated

January 25, 2013

Record last verified: 2013-01

Locations

CH(2)