Fracture HealingNCT04783337
Local Remodelling of Bone Fracture Healing
A study testing HR-pQCT (high resolution computertomograph) and Blood withdrawal in people with Fracture Healing and Distal Radius Fracture, run by Medical University Innsbruck.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fracture Healing, Distal Radius Fracture
- What is being tested?
- HR-pQCT (high resolution computertomograph) and Blood withdrawal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2015to 19 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age under 18
- Comminuted fracture
- Bilateral spoke fracture
- unstable fracture with indication for surgical treatment
- open spoke fracture
- Adjacent fractures or injuries
Show all 17Show fewer
- 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
About this study
Official title: Local Remodelling and Mechanoregulation of Bone Fracture Healing in Healthy, Aged, and Osteoporotic Humans
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.
Read the 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.
- Conditions
- Fracture Healing, Distal Radius Fracture
- Being tested
- HR-pQCT (high resolution computertomograph), Blood withdrawal
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCT (high resolution computertomograph)Diagnostic test
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 withdrawalDiagnostic test
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)
| Study group | Role | What they receive |
|---|---|---|
| HR-pQCT (high resolution computertomograph) | Experimental | 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". Receives: Diagnostic Test: HR-pQCT (high resolution computertomograph); Diagnostic Test: Blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Strength analysis of the distal radius fracture
The aim of our study is to create a mathematical model of human bone healing using the example of a distal radius 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.(finite element analysis- FEA)
Measured: 1 year
Secondary outcomes (6)
Rate of bone density
Amount of bone mineral in bone tissue, using DXA Scan (Dual-xray absorbtiometry).
Measured: 1year
Bone remodeling markers (blood analysis)
Concentration of bone remodeling markers of (sober) blood samples with signs of healing in hr-pqCT and conventional X-rays. Blood markers of bone remodeling are: 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).
Increaseing bone turnover values during healing period.
Measured: 1year
Patient Reported Outcome (function)
Percentage of the patients with reduced or normal outcome after fractures using questionnaires like the Michigan Wrist Score in correlation of the healing process. This is a score reporting the functional outcome, satisfaction and quality of life. Best score is 100%, least score 0%.
Measured: 1 year
Patient Reported Outcome (pain)
Percentage of the patients with remaining pain after fracture using the visual analog scale in correlation of the healing process. The scale reports about the intensity of pain. The maximum pain and least score is 10, and the best score is 0 which means "no pain".
Measured: 1 year
Clinical outcome (range of motion)
Degree of the possible range of motion using a goniometer to measure the movement angles in correlation of the healing process. The better the range of motion the higher the value. Normally the following limits are given:
Radial: least 0 degree, maximum: 20 degree Ulnar: least 0 degree, maximum: 40 degree Extension: least 0 degree, maximum: 70 degree Flexion: least 0 degree, maximum: 70 degree Pronation: least 0 degree, maximum: 90 degree Supination: least 0 degree, maximum: 90 degree
Measured: 1 year
Clinical outcome (grip strength wrist)
Extent of possible grip strength measurement using dynanometer in correlation of the healing process.
Minimum: 0 kilogram Maximum: 80 kg
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start10 Dec 2015
- Primary completion17 Jan 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture HealingStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich, University Hospital Ulm
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783337
- Sponsor's protocol ID
- I-3258-B27_microCT Radius
- Status last verified
- Feb 2021
- First submitted
- 15 Feb 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Remodelling and Mechanoregulation of Bone Fracture Healing in Healthy, Aged, and Osteoporotic Humans
- ClinicalTrials.gov ID
- NCT04783337
- Acronym / sponsor ID
- I-3258-B27_microCT Radius
- Conditions
- Fracture Healing, Distal Radius Fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- ETH Zurich, University Hospital Ulm
- Study start
- 10 Dec 2015 (actual)
- Primary completion
- 17 Jan 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HR-pQCT (high resolution computertomograph) | Experimental | Diagnostic Test: HR-pQCT (high resolution computertomograph), Diagnostic Test: Blood withdrawalThis 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". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- Age under 18
- Comminuted fracture
- Bilateral spoke fracture
- unstable fracture with indication for surgical treatment
- open spoke fracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | HR-pQCT (high resolution computertomograph) |
| Blood withdrawalBone 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) | Diagnostic test | HR-pQCT (high resolution computertomograph) |
Primary outcome
Strength analysis of the distal radius fracture
Time frame: 1 year
The aim of our study is to create a mathematical model of human bone healing using the example of a distal radius 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.(finite element analysis- FEA)
6 secondary outcomes
Rate of bone density
Time frame: 1year
Bone remodeling markers (blood analysis)
Time frame: 1year
Patient Reported Outcome (function)
Time frame: 1 year
Patient Reported Outcome (pain)
Time frame: 1 year
Clinical outcome (range of motion)
Time frame: 1 year
Clinical outcome (grip strength wrist)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing HR-pQCT (high resolution computertomograph) and Blood withdrawal in people with Fracture Healing and Distal Radius Fracture, run by Medical University Innsbruck.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength analysis of the distal radius fracture (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.