Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
106 participants
INTERVENTIONAL
2015-12-10
2019-12-19
Brief Summary
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Detailed Description
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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: 0.02 mSv / image; HR-pQCT: between 0.003 - 0.006 mSv / stack image). The DXA examination on the distal radius, femur / hip + lumbar spine requires 0.405 mSv. With 18 x-rays and 24 HR-pQCTs and 1 DXA per patient, there is a radiation exposure of 0.837 - 0.909 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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HR-pQCT (high resolution computertomograph)
This arm is the inverventional group for all collected cases. No other arms are available as comparator or control. All patients are treated the same.
Description of the intervention in the section "Intervention".
HR-pQCT (high resolution computertomograph)
In addition to determining the bone density, a quantitative bone structure analysis with measurement of the number of thickness and distribution of the trabeculae can also be carried out. In addition, the finite element analysis (FEA) allows strength models of the examined bone to be created from the data of the hr-pqCTs. In this way, the osseous consolidation of the fracture can not only be observed, but also tested for resilience with the help of mathematical models.
Blood withdrawal
Bone remodeling blood marker: S-CTX (Crosslaps), S-TRA5b ( tartrate-resistant acid phosphatase), S-PINP (Procollagen type 1 amino-terminal propeptide), BALP, Calcium, parathyroid hormone, 25-OH-Vitamin D3 (HPLC)
Interventions
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HR-pQCT (high resolution computertomograph)
In addition to determining the bone density, a quantitative bone structure analysis with measurement of the number of thickness and distribution of the trabeculae can also be carried out. In addition, the finite element analysis (FEA) allows strength models of the examined bone to be created from the data of the hr-pqCTs. In this way, the osseous consolidation of the fracture can not only be observed, but also tested for resilience with the help of mathematical models.
Blood withdrawal
Bone remodeling blood marker: S-CTX (Crosslaps), S-TRA5b ( tartrate-resistant acid phosphatase), S-PINP (Procollagen type 1 amino-terminal propeptide), BALP, Calcium, parathyroid hormone, 25-OH-Vitamin D3 (HPLC)
Eligibility Criteria
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Inclusion Criteria
* Conservatively treated distal radius fracture
* Able and agree to sign a written consent
* Able and agree to attend the follow-up examinations
* Able to understand the national language both in writing and orally to a minimum
Exclusion Criteria
* Comminuted fracture
* Bilateral spoke fracture
* unstable fracture with indication for surgical treatment
* open spoke fracture
* Adjacent fractures or injuries
* Previous injury to the distal radius
* The patient cannot give consent due to physical or mental disabilities
* Patient is not available for regular check-ups (abroad)
* The patient does not have full legal capacity
* Alcohol and drug abuse
* Current treatment with steroids
* Multiple trauma
* Illnesses or disorders that restrict the movement of a hand (apoplexy, hemiparesis, neuromuscular or rheumatic disease, severe mental or metabolic diseases)
* Rheumatoid arthritis
* Previous radio or chemotherapy within the last year
* Currently participating in a pharmaceutical study
ALL
No
Sponsors
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ETH Zurich
OTHER
University Hospital Ulm
OTHER
Medical University Innsbruck
OTHER
Responsible Party
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Other Identifiers
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I-3258-B27_microCT Radius
Identifier Type: -
Identifier Source: org_study_id
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