Clinical trial NCT04783337: Local Remodelling of Bone Fracture Healing
Official title: Local Remodelling and Mechanoregulation of Bone Fracture Healing in Healthy, Aged, and Osteoporotic Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fracture Healing
Distal Radius Fracture
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: ETH Zurich
name: University Hospital Ulm
First posted: 2021-03-05
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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: 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.

Eligibility criteria: Inclusion Criteria:

* Age 18+
* 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:

* Age under 18
* 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

Primary outcomes:
measure: Strength analysis of the distal radius fracture
timeFrame: 1 year
Secondary outcomes:
measure: Rate of bone density
timeFrame: 1year
measure: Bone remodeling markers (blood analysis)
timeFrame: 1year
measure: Patient Reported Outcome (function)
timeFrame: 1 year
measure: Patient Reported Outcome (pain)
timeFrame: 1 year
measure: Clinical outcome (range of motion)
timeFrame: 1 year
measure: Clinical outcome (grip strength wrist)
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
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