Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04783337
Status:
COMPLETED
Last Update Posted:
2021-03-05
First Post:
2021-02-15
Brief Title:
Local Remodelling of Bone Fracture Healing
Sponsor:
Medical University Innsbruck
Organization:
Medical University Innsbruck
Study Overview
Official Title:
Local Remodelling and Mechanoregulation of Bone Fracture Healing in Healthy Aged and Osteoporotic Humans
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of our study is to improve a mathematical model FAE of human bone healing using the example of the distal spoke fracture Computer-aided strength analyzes of data from hr-pqCTs should provide information about the fracture strength and quality of the newly formed bone at defined times Laboratory parameters from sober blood analyzes bone remodeling markers competitive x-rays the course of pain range of motion grip strength and other easily accessible parameters should be evaluated with the above-mentioned analyzes
Detailed Description:
So far empirical values have mainly been used to assess fracture healing The clinical parameter used is freedom from pain over the fracture and native radiology the callus formation In the case of anatomically reduced fractures however this can hardly be observed In the case of a distal radius fracture it is assumed that the total time to complete healing and resilience is one year However this has not been proven biomechanically
The high-resolution peripheral quantitative computed tomography offers the possibility of precisely describing the healing process in the high-resolution range using the trabecular structure bone density bone volume and tissue composition The finite element analysis can then be used to calculate the load-bearing capacity of the bone and to create failure models The distal radius fracture is one of the most common fractures in humans especially in osteoporosis Due to its frequency and easily accessible fracture localization it is an ideal model for investigating fracture healing The additional examination of blood and urine for bone loss markers can provide further information on the healing process in conjunction with the image data
It is a prospective cohort study The collected data are compared on the one hand with preliminary examinations of the injured side in the sense of creating a model and on the other hand with the healthy non-fractured side in order to compare the strength of the fracture
Performing the X-ray and HR-pQCTs leads to radiation exposure which however can be classified as low X-ray 002 mSv image HR-pQCT between 0003 - 0006 mSv stack image The DXA examination on the distal radius femur hip lumbar spine requires 0405 mSv With 18 x-rays and 24 HR-pQCTs and 1 DXA per patient there is a radiation exposure of 0837 - 0909 mSv over the course of the academic year
Blood will also be taken and urine samples will be collected Together with the clinical examination and filling in the questionnaire each examination should take approx 45 minutes
The high-resolution peripheral quantitative computed tomography offers the possibility of precisely describing the healing process in the high-resolution range using the trabecular structure bone density bone volume and tissue composition The finite element analysis can then be used to calculate the load-bearing capacity of the bone and to create failure models The distal radius fracture is one of the most common fractures in humans especially in osteoporosis Due to its frequency and easily accessible fracture localization it is an ideal model for investigating fracture healing The additional examination of blood and urine for bone loss markers can provide further information on the healing process in conjunction with the image data
It is a prospective cohort study The collected data are compared on the one hand with preliminary examinations of the injured side in the sense of creating a model and on the other hand with the healthy non-fractured side in order to compare the strength of the fracture
Performing the X-ray and HR-pQCTs leads to radiation exposure which however can be classified as low X-ray 002 mSv image HR-pQCT between 0003 - 0006 mSv stack image The DXA examination on the distal radius femur hip lumbar spine requires 0405 mSv With 18 x-rays and 24 HR-pQCTs and 1 DXA per patient there is a radiation exposure of 0837 - 0909 mSv over the course of the academic year
Blood will also be taken and urine samples will be collected Together with the clinical examination and filling in the questionnaire each examination should take approx 45 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None