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

This study has been terminated.
(Interim analysis showed statistically significant results)
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation Identifier:
First received: January 13, 2009
Last updated: October 7, 2011
Last verified: October 2011

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 Intervention
Femoral Fractures Hip Fractures Osteoporosis Bone Density Device: DensiProbe Hip

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by AO Clinical Investigation and Documentation:

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 198
Study Start Date: November 2008
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00822159

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
Principal Investigator: Norbert Suhm, MD Universitätsspital Basel
  More Information

Additional Information:
Responsible Party: AO Clinical Investigation and Documentation Identifier: NCT00822159     History of Changes
Other Study ID Numbers: Densiprobe-08
Study First Received: January 13, 2009
Last Updated: October 7, 2011

Keywords provided by AO Clinical Investigation and Documentation:
Fixation failure
Bone strength

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Femoral Fractures
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Hip Injuries
Leg Injuries processed this record on September 21, 2017