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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)
Sponsor:
Information provided by (Responsible Party):
AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier:
NCT00822159
First received: January 13, 2009
Last updated: October 7, 2011
Last verified: October 2011
History of Changes
  Purpose

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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of complications [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • BMD values measured by DXA (contralateral hip) [ Time Frame: Post OP ] [ Designated as safety issue: No ]
  • Parker mobility score [ Time Frame: 3 months ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00822159

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: AO Clinical Investigation and Documentation
ClinicalTrials.gov Identifier: NCT00822159     History of Changes
Other Study ID Numbers: Densiprobe-08
Study First Received: January 13, 2009
Last Updated: October 7, 2011
Health Authority: Switzerland: Ethikkommission

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

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Hip Fractures
Osteoporosis
Wounds and Injuries
 Leg Injuries
Hip Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on May 19, 2013