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Examination of Bone Defects and Microcirculation Using Volume Computed Tomography and Dynamic Contrast-enhanced Magnetic Resonance Imaging


N/A
18 Years
N/A
Open (Enrolling)
Both
Osteoporosis, Multiple Myeloma, Vertebral Fracture

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Trial Information

Examination of Bone Defects and Microcirculation Using Volume Computed Tomography and Dynamic Contrast-enhanced Magnetic Resonance Imaging


In 30 patients with confirmed osteoporosis and vertebral fracture(s) dynamic
contrast-enhanced MRI (DCE-MRI)and diffusion weighted imaging (DWI) of the vertebral column
will be performed. Furthermore, 30 patients will be examined before and after insertion of
foreign material as well as 2 weeks, 1 month and 4 months after surgery to investigate
healing processes at the interface of bone and xenomaterial. New magnetic resonance imaging
(MRI) sequences will be developed to improve the detection of osseous microstructure.

In an experimental study, mice, rats and sheep with and without an osteoporotic phenotype
will be imaged with VCT, morphologic MRI, DCE-MRI and DWI. Using these methods, bone
structure, vascularization and cellularity will be assessed in control and osteoporotic
animals. Furthermore, these morphological and functional imaging techniques will be applied
before and after implantation of biomaterials in bone in order to characterize morphological
and functional changes in bone upon implantation of these biomaterials.


Inclusion Criteria:



- benign osteoporosis

Exclusion Criteria:

- contra-indications for MRI

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Changes of microcirculation at the interface between bone and implanted xenomaterial in patients with osteoporosis or multiple myeloma

Outcome Description:

This is a study within a multicenter multiproject frame. Development of bone-stabilizing implant material designed to stimulate the formation and regeneration of physiologically structured bone after vertebral collapse will be investigated. The subproject examins the interaction between host and graft. Hypothesis: Implanted materials will function as a framework for osteogenesis, and successful integration of the foreign material goes along with transient increase in microcirculation. Amplitude A and exchange rate constant kep of DCE-MRI will be measured to detect changes in microcirculation.

Outcome Time Frame:

before (baseline)and after intervention, in follow-up 2 weeks, 1 month, 4 months after intervention

Safety Issue:

No

Principal Investigator

Reinhard Schnettler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gie├čen University, Heidelberg

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

Transregio79B8

NCT ID:

NCT01374412

Start Date:

July 2010

Completion Date:

July 2022

Related Keywords:

  • Osteoporosis
  • Multiple Myeloma
  • Vertebral Fracture
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Osteoporosis
  • Spinal Fractures

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