Status:
TERMINATED
Influence of Bone Strength Measured by DensiProbe on Bone Related Fixation Failure
Lead Sponsor:
AO Clinical Investigation and Publishing Documentation
Conditions:
Femoral Fractures
Hip Fractures
Eligibility:
All Genders
50+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT00822159
Start Date
November 1 2008
End Date
September 1 2011
Last Update
October 10 2011
Active Locations (8)
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1
Medizinische Universität
Innsbruck, Austria
2
Wilhelminenspital
Vienna, Austria
3
Medizinische Hochschule Hannover
Hanover, Germany
4
Friedrich-Schiller Universität
Jena, Germany