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Influence of Bone Strength Measured by DensiProbe on Bone Related Fixation Failure (Densiprobe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00822159
Recruitment Status : Terminated (Interim analysis showed statistically significant results)
First Posted : January 14, 2009
Last Update Posted : October 10, 2011
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Femoral Fractures Hip Fractures Osteoporosis Bone Density Device: DensiProbe Hip Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Study Start Date : November 2008
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Device: 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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Rate of complications [ Time Frame: 3 months ]
  2. BMD values measured by DXA (contralateral hip) [ Time Frame: Post OP ]
  3. Parker mobility score [ Time Frame: 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00822159

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Medizinische Universität
Innsbruck, Austria
Wien, Austria
Medizinische Hochschule Hannover
Hannover, Germany
Friedrich-Schiller Universität
Jena, Germany
Universitätsklinikum Münster
Münster, Germany
Twenteborg Ziekenhuis Almelo
Almelo, Netherlands
Basel, BS, Switzerland, 4031
Stadtspital Triemli
Zürich, Switzerland
Sponsors and Collaborators
AO Clinical Investigation and Documentation
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Principal Investigator: Norbert Suhm, MD Universitätsspital Basel

Additional Information:
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Responsible Party: AO Clinical Investigation and Documentation Identifier: NCT00822159     History of Changes
Other Study ID Numbers: Densiprobe-08
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: October 10, 2011
Last Verified: October 2011
Keywords provided by AO Clinical Investigation and Documentation:
Fixation failure
Bone strength
Additional relevant MeSH terms:
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Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Hip Injuries
Leg Injuries