Influence of Bone Strength Measured by DensiProbe on Bone Related Fixation Failure
NCT ID: NCT00822159
Last Updated: 2011-10-10
Study Results
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Basic Information
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TERMINATED
NA
198 participants
INTERVENTIONAL
2008-11-30
2011-09-30
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Interventions
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DensiProbe Hip
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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AO Clinical Investigation and Publishing Documentation
OTHER
Responsible Party
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Principal Investigators
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Norbert Suhm, MD
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Basel
Locations
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Medizinische Universität
Innsbruck, , Austria
Wilhelminenspital
Vienna, , Austria
Medizinische Hochschule Hannover
Hanover, , Germany
Friedrich-Schiller Universität
Jena, , Germany
Universitätsklinikum Münster
Münster, , Germany
Twenteborg Ziekenhuis Almelo
Almelo, , Netherlands
Universitätsspital
Basel, Canton of Basel-City, Switzerland
Stadtspital Triemli
Zurich, , Switzerland
Countries
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Related Links
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Related Info
Other Identifiers
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Densiprobe-08
Identifier Type: -
Identifier Source: org_study_id