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

January 13, 2009
October 7, 2011
November 2008
September 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00822159 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Influence of Bone Strength Measured by DensiProbe on Bone Related Fixation Failure
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Femoral Fractures
  • Hip Fractures
  • Osteoporosis
  • Bone Density
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
198
September 2011
September 2011   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Austria,   Switzerland,   Netherlands
 
NCT00822159
Densiprobe-08
No
AO Clinical Investigation and Documentation
AO Clinical Investigation and Documentation
Not Provided
Principal Investigator: Norbert Suhm, MD Universitätsspital Basel
AO Clinical Investigation and Documentation
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP