Pilot Study to Evaluate Feasibility of DensiProbe Spine Assessing Bone Strength in Spinal Surgery

NCT ID: NCT01126385

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2012-08-31

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.

Detailed Description

Osteoporotic fragility fractures often occur in the spine. A common surgical technique is the transpedicular fixation using pedicle screws. A major complication of this treatment is a cut-out or back-out of the screw due to insufficient anchorage of the implant in the vertebral body.

A new mechanical device was developed in order to provide the surgeon with intraoperative information about the mechanical strength of the cancellous bone. In cases of low bone quality, the treatment can be adapted to the patient's condition, for example by augmentation of the screw anchorage using bone cement. However, this treatment involves a risk of cement leakage and subsequent pulmonary embolism or nerve damage. Furthermore, cement augmentation is time-consuming. Therefore, there is a need for a diagnostic device that can intraoperatively support the surgeon's decision on the appropriate treatment.

DensiProbe Spine was developed accordingly to the clinically approved DensiProbe Hip, which was designed for the same diagnostic reasons in patients with hip fractures undergoing fracture fixation with the dynamic hip screw (DHS). However, the application of bone strength measurements in the spine is in so far different to the hip as the anatomical dimensions in the spine are much smaller and lower values of bone mineral density (BMD) and bone strength are expected.

The objective of this pilot study is to investigate the handling and feasibility of the newly developed DensiProbe Spine measurement device. In case of a positive result of the pilot study, a multicenter cohort study will be performed in order to clinically validate the DensiProbe Spine device by assessing the correlation between DensiProbe Spine measurements and the amounts of pedicle screw migration in patients undergoing transpedicular fixation.

Conditions

Spinal Diseases

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Transpedicular stabilization

Patients undergoing transpedicular stabilization of the spine

DensiProbe Spine

Intervention Type: DEVICE

Intraoperative DensiProbe Spine measurements

Interventions

DensiProbe Spine

Intraoperative DensiProbe Spine measurements

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

AO Clinical Investigation and Publishing Documentation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lorin M Benneker, MD

Role: PRINCIPAL_INVESTIGATOR

Insel Gruppe AG, University Hospital Bern

Locations

Klinik Sonnenhof

Bern, Canton of Bern, Switzerland

Inselspital

Bern, Canton of Bern, Switzerland

Countries

Switzerland

Other Identifiers

DensiProbe Spine 2010

Identifier Type: -

Identifier Source: org_study_id