Spinal DiseasesDensiProbeNCT01126385
Pilot Study to Evaluate Feasibility of DensiProbe Spine Assessing Bone Strength in Spinal Surgery
An observational study of Spinal Diseases, run by AO Clinical Investigation and Publishing Documentation at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Diseases
- What is being tested?
- DensiProbe Spine
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Aug 2010to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing transpedicular stabilization of the spine
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Klinik Sonnenhof
Bern, Canton of Bern, 3006
Inselspital
Bern, Canton of Bern, 3010
About this study
Official title: A Prospective Case Series to Evaluate Handling and Feasibility of DensiProbe Spine Assessing Vertebral Bone Strength in Patients Undergoing Transpedicular Fixation of the Spine - a Pilot Study
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.
Read the 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
- Being tested
- DensiProbe Spine
- Keywords
- Spinal Diseases, Bone strength, Transpedicular fixation, Dorsal instrumentation, DensiProbe
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DensiProbe SpineDevice
Intraoperative DensiProbe Spine measurements
| Study group | Role | What they receive |
|---|---|---|
| Transpedicular stabilization | Patients undergoing transpedicular stabilization of the spine Receives: Device: DensiProbe Spine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 2 months postsurgery
Secondary outcomes (4)
Bone mineral density
The bone mineral density will be measured preoperatively in the lumbar spine (L1-L4) using DXA in order to assess local bone status.
Measured: Baseline
Pedicle screw migration
The migration of the pedicle screw will be performed by measuring the angle between the pedicle screw axis and the caudal endplate. The amount of screw migration is defined as the difference in that angle between the baseline (postoperative) and the two month lateral x-rays
Measured: 2 months postsurgery
QCT analysis of bone biopsies
For each vertebral body under investigation a probe of trabecular bone is obtained to determine bone quality using quantitative micro-CT analysis
Measured: Baseline
Application of bone cement
For each patient the surgeon decides whether or not augmentation with bone cement is necessary
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startAug 2010
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
- Investigators
- Lorin M Benneker, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126385
- Sponsor's protocol ID
- DensiProbe Spine 2010
- Acronym
- DensiProbe
- Status last verified
- Jan 2013
- First submitted
- 18 May 2010
- Last updated
- 25 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Case Series to Evaluate Handling and Feasibility of DensiProbe Spine Assessing Vertebral Bone Strength in Patients Undergoing Transpedicular Fixation of the Spine - a Pilot Study
- ClinicalTrials.gov ID
- NCT01126385
- Acronym / sponsor ID
- DensiProbe / DensiProbe Spine 2010
- Conditions
- Spinal Diseases
- Keywords
- Spinal Diseases, Bone strength, Transpedicular fixation, Dorsal instrumentation, DensiProbe
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Aug 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transpedicular stabilization | – | Device: DensiProbe SpinePatients undergoing transpedicular stabilization of the spine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing transpedicular stabilization of the spine
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DensiProbe SpineIntraoperative DensiProbe Spine measurements | Device | Transpedicular stabilization |
Primary outcome
Surgeon's compliance- and handling-oriented questionnaire
Time frame: Baseline
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
Intra- and post-operative adverse events
Time frame: Up to 2 months postsurgery
All intra- and postoperative adverse events will be assessed and analyzed regarding their relationship to the study device
4 secondary outcomes
Bone mineral density
Time frame: Baseline
Pedicle screw migration
Time frame: 2 months postsurgery
QCT analysis of bone biopsies
Time frame: Baseline
Application of bone cement
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2013.
Related trials for Spinal Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
Recruiting
MyHand-SCI: An Active Hand Orthosis for Spinal Cord Injury
Spinal Cord Injuries, Tetraplegia
RecruitingPhase 1/2
Study is to Assess the Safety and Tolerability of VTx-002 in Participants With ALS
Amyotrophic Lateral Sclerosis
Not yet recruiting
A Study on the Addition of Alsum30 for the Treatment of Amyotrophic Lateral Sclerosis
Amyotrophic Lateral Sclerosis (ALS), Bacillus Coagulans
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorin M Benneker, MD principal investigator
Insel Gruppe AG, University Hospital Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Diseases, run by AO Clinical Investigation and Publishing Documentation at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgeon's compliance- and handling-oriented questionnaire (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2013.