search
Back to results

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
Medical University Innsbruck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fracture Healing

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 15, 2021
    Last Updated
    March 2, 2021
    Sponsor
    Medical University Innsbruck
    Collaborators
    ETH Zurich, University Hospital Ulm
    search

    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

    Learn more about this trial

    Local Remodelling of Bone Fracture Healing

    We'll reach out to this number within 24 hrs