Local Remodelling of Bone Fracture Healing
Primary Purpose
Fracture Healing, Distal Radius Fracture
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HR-pQCT (high resolution computertomograph)
Blood withdrawal
Sponsored by
About this trial
This is an interventional basic science trial for Fracture Healing
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HR-pQCT (high resolution computertomograph)
Arm Description
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".
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Rate of bone density
Amount of bone mineral in bone tissue, using DXA Scan (Dual-xray absorbtiometry).
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.
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%.
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".
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
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
Full Information
NCT ID
NCT04783337
First Posted
February 15, 2021
Last Updated
March 2, 2021
Sponsor
Medical University Innsbruck
Collaborators
ETH Zurich, University Hospital Ulm
1. Study Identification
Unique Protocol Identification Number
NCT04783337
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2015 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University Innsbruck
Collaborators
ETH Zurich, University Hospital Ulm
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fracture Healing, Distal Radius Fracture
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HR-pQCT (high resolution computertomograph)
Arm Type
Experimental
Arm Description
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".
Intervention Type
Diagnostic Test
Intervention Name(s)
HR-pQCT (high resolution computertomograph)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood withdrawal
Intervention Description
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)
Primary Outcome Measure Information:
Title
Strength analysis of the distal radius fracture
Description
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)
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Rate of bone density
Description
Amount of bone mineral in bone tissue, using DXA Scan (Dual-xray absorbtiometry).
Time Frame
1year
Title
Bone remodeling markers (blood analysis)
Description
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.
Time Frame
1year
Title
Patient Reported Outcome (function)
Description
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%.
Time Frame
1 year
Title
Patient Reported Outcome (pain)
Description
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".
Time Frame
1 year
Title
Clinical outcome (range of motion)
Description
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
Time Frame
1 year
Title
Clinical outcome (grip strength wrist)
Description
Extent of possible grip strength measurement using dynanometer in correlation of the healing process.
Minimum: 0 kilogram Maximum: 80 kg
Time Frame
1 year
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
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Local Remodelling of Bone Fracture Healing
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