Femoral FracturesDensiprobeNCT00822159
Influence of Bone Strength Measured by DensiProbe on Bone Related Fixation Failure
A study testing DensiProbe Hip in people with Femoral Fractures and Hip Fractures, run by AO Clinical Investigation and Publishing Documentation at 8 sites in 4 countries.
Trial summary
Hip fractures mostly occur in elderly people with low bone strength. Bone strength is determined by bone mineral density (BMD), bone turnover, microarchitectural and geometrical properties of the bone. Dual energy x-ray absorptiometry (DXA) is the standard technique to measure BMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Femoral Fractures, Hip Fractures, Osteoporosis
- What is being tested?
- DensiProbe Hip
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2008to Sep 2011
- Phase
- Interventional
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 50 years or older
- Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3
- Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)
- Patients willing to participate in the study according to the clinical investigation plan
- Patients able to understand and read country national language at an elementary level
- Signed written informed consent by the patient or legal guardian
Who cannot join
- Bilateral hip fractures (at present or in the past)
- Open hip fracture
- Any previous surgical procedures of the hip (ipsilateral / contralateral)
- More than 7 days between injury and surgery
- Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)
- Patients being pregnant or breast-feeding
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- Pathologic fractures
- Active malignancy
- Psychiatric disorders that would preclude reliable assessment (e.g. severe depression)
- Drug or alcohol abuse
- Patients having participated in any other device or drug related clinical trial within the previous month
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Germany3 sites
Medizinische Hochschule Hannover
Hanover
Friedrich-Schiller Universität
Jena
Universitätsklinikum Münster
Münster
Switzerland2 sites
Universitätsspital
Basel, Canton of Basel-City, 4031
Stadtspital Triemli
Zurich
About this study
Official title: Prospective Multicenter Cohort Study to Evaluate the Influence of Bone Strength Measured by DensiProbe Hip on Bone Related Fixation Failure in Patients With Hip Fractures Undergoing DHS Surgical Treatment.
Hip fractures mostly occur in elderly people with low bone strength. Bone strength is determined by bone mineral density (BMD), bone turnover, microarchitectural and geometrical properties of the bone. Dual energy x-ray absorptiometry (DXA) is the standard technique to measure BMD. However, BMD just provides information regarding the quantity of mineral in bone, which is only one component of bone strength. To date there is no reliable method to assess bone strength in vivo. Therefore, a method to assess bone strength beyond BMD would provide additional information regarding the patients' risk of bone related fixation failure after fracture fixation.
DensiProbe is a new diagnostic device that was developed for intra-operative assessment of mechanical stability of the bone in the proximal femur. It consists of a drill bit like tool and an electronic system to measure the peak torque to break-away of trabecular bone in the femoral head of patients undergoing DHS surgical treatment. In a cadaver study comparing bone mineral density measured by quantitative computed tomography with bone strength measured by DensiProbe a high correlation between these two parameters could be shown. In a clinical pilot study a significant correlation between DensiProbe measurements and BMD measured by DXA at the femoral neck in patients with hip fractures could be shown. However, no perfect correlation was expected because DensiProbe measures bone strength, which is only partly caused by BMD.
Read more
Bone related fixation failure, such as secondary loss of reduction, is influenced by bone strength, bone mineral density, fracture type, fracture reduction and primary positioning of the implant. The predictive value of DensiProbe measurements for secondary loss of reduction needs to be investigated. If DensiProbe turned out to be an effective screening tool for patients with low bone strength that are on higher risk of the aforementioned complications these patients may in future benefit from alternative treatment methods (e.g. augmentation techniques) in order to reduce bone related fixation failure.
The primary aim of the present study is to investigate if bone strength measured by DensiProbeTM Hip (DensiProbe) is an independent factor to predict secondary loss of reduction (screw migration of 5 mm or more and / or telescoping of 10 mm or more) in patients with hip fractures after fracture fixation with DHS.
- Conditions
- Femoral Fractures, Hip Fractures, Osteoporosis, Bone Density
- Being tested
- DensiProbe Hip
- Keywords
- Fixation failure, Bone strength, DensiProbe
- Medical subject headings
- Femoral Fractures, Hip Fractures, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DensiProbe HipDevice
DensiProbe (CE marked) is a mechanical probe, which is used intra-operatively to assess mechanical stability of the trabecular bone in the proximal femur. It consists of a drill bit like tool and an electronic system for measuring the peak torque to break-away of trabecular bone in the femoral head. DensiProbe measurements are designed to be integrated in the DHS surgical procedure.
What is being measured
The primary outcome is the main question the study is designed to answer.
Migration of the screw in relation to the femoral head of 5 mm or more and/or Telescoping (shortening of the femoral neck) of 10 mm or more
Measured: 3 months
Secondary outcomes (3)
Rate of complications
Measured: 3 months
BMD values measured by DXA (contralateral hip)
Measured: Post OP
Parker mobility score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionSep 2011
- Study completionSep 2011
Why it stopped: Interim analysis showed statistically significant results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FracturesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AO Clinical Investigation and Publishing Documentation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Norbert Suhm, MD, Principal investigator, Universitätsspital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822159
- Sponsor's protocol ID
- Densiprobe-08
- Acronym
- Densiprobe
- Status last verified
- Oct 2011
- First submitted
- 13 Jan 2009
- Last updated
- 10 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Cohort Study to Evaluate the Influence of Bone Strength Measured by DensiProbe Hip on Bone Related Fixation Failure in Patients With Hip Fractures Undergoing DHS Surgical Treatment.
- ClinicalTrials.gov ID
- NCT00822159
- Acronym / sponsor ID
- Densiprobe / Densiprobe-08
- Conditions
- Femoral Fractures, Hip Fractures, Osteoporosis, Bone Density
- Keywords
- Fixation failure, Bone strength, DensiProbe
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed statistically significant results
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- AO Clinical Investigation and Publishing DocumentationUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jan 2009 (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.
Hip fractures mostly occur in elderly people with low bone strength. Bone strength is determined by bone mineral density (BMD), bone turnover, microarchitectural and geometrical properties of the bone. Dual energy x-ray absorptiometry (DXA) is the standard technique to measure BMD. However, BMD just provides information regarding the quantity of mineral in bone, which is only one component of bone strength. To date there is no reliable method to assess bone strength in vivo. Therefore, a method to assess bone strength beyond BMD would provide additional information regarding the patients' risk of bone related fixation failure after fracture fixation.
DensiProbe is a new diagnostic device that was developed for intra-operative assessment of mechanical stability of the bone in the proximal femur. It consists of a drill bit like tool and an electronic system to measure the peak torque to break-away of trabecular bone in the femoral head of patients undergoing DHS surgical treatment. In a cadaver study comparing bone mineral density measured by quantitative computed tomography with bone strength measured by DensiProbe a high correlation between these two parameters could be shown. In a clinical pilot study a significant correlation between DensiProbe measurements and BMD measured by DXA at the femoral neck in patients with hip fractures could be shown. However, no perfect correlation was expected because DensiProbe measures bone strength, which is only partly caused by BMD.
Bone related fixation failure, such as secondary loss of reduction, is influenced by bone strength, bone mineral density, fracture type, fracture reduction and primary positioning of the implant. The predictive value of DensiProbe measurements for secondary loss of reduction needs to be investigated. If DensiProbe turned out to be an effective screening tool for patients with low bone strength that are on higher risk of the aforementioned complications these patients may in future benefit from alternative treatment methods (e.g. augmentation techniques) in order to reduce bone related fixation failure.
The primary aim of the present study is to investigate if bone strength measured by DensiProbeTM Hip (DensiProbe) is an independent factor to predict secondary loss of reduction (screw migration of 5 mm or more and / or telescoping of 10 mm or more) in patients with hip fractures after fracture fixation with DHS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients 50 years or older
- Patients with trochanteric or femoral neck fractures, classified as: AO 31-A1, AO 31-A2, AO 31-A3, AO 31-B1, AO 31-B2, AO 31-B3
- Patients undergoing fixation with DHS (135° aiming device, anti-rotational K-wire)
- Patients willing to participate in the study according to the clinical investigation plan
- Patients able to understand and read country national language at an elementary level
Key exclusion criteria (11 listed)
- Bilateral hip fractures (at present or in the past)
- Open hip fracture
- Any previous surgical procedures of the hip (ipsilateral / contralateral)
- More than 7 days between injury and surgery
- Polytrauma (multiple injuries, whereof one or the combination of several injuries is life-threatening)
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 HipDensiProbe (CE marked) is a mechanical probe, which is used intra-operatively to assess mechanical stability of the trabecular bone in the proximal femur. It consists of a drill bit like tool and an electronic system for measuring the peak torque to break-away of trabecular bone in the femoral head. DensiProbe measurements are designed to be integrated in the DHS surgical procedure. | Device | – |
Primary outcome
Migration of the screw in relation to the femoral head of 5 mm or more and/or Telescoping (shortening of the femoral neck) of 10 mm or more
Time frame: 3 months
3 secondary outcomes
Rate of complications
Time frame: 3 months
BMD values measured by DXA (contralateral hip)
Time frame: Post OP
Parker mobility score
Time frame: 3 months
Results and safety
The study was stopped early (reason given: Interim analysis showed statistically significant results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2011.
- Related InfoLink provided by the sponsor.
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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.
Norbert Suhm, MD principal investigator
Universitätsspital Basel
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DensiProbe Hip in people with Femoral Fractures and Hip Fractures, run by AO Clinical Investigation and Publishing Documentation at 8 sites in 4 countries.
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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 10 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Austria, Switzerland, Netherlands. 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 was stopped early (reason given: Interim analysis showed statistically significant results). Results are not available in the source record.
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?
Migration of the screw in relation to the femoral head of 5 mm or more and/or Telescoping (shortening of the femoral neck) of 10 mm or more (time frame: 3 months). 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 10 Oct 2011.