NCT04783337

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2019

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 5, 2021

Completed
Last Updated

March 5, 2021

Status Verified

February 1, 2021

Enrollment Period

3.1 years

First QC Date

February 15, 2021

Last Update Submit

March 2, 2021

Conditions

Fracture HealingDistal Radius Fracture

Outcome Measures

Primary Outcomes (1)

  • 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)

    1 year

Secondary Outcomes (6)

  • Rate of bone density

    1year

  • Bone remodeling markers (blood analysis)

    1year

  • Patient Reported Outcome (function)

    1 year

  • Patient Reported Outcome (pain)

    1 year

  • Clinical outcome (range of motion)

    1 year

  • +1 more secondary outcomes

Study Arms (1)

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".

Diagnostic Test: HR-pQCT (high resolution computertomograph)Diagnostic Test: Blood withdrawal

Interventions

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.

HR-pQCT (high resolution computertomograph)
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)

HR-pQCT (high resolution computertomograph)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2021

First Posted

March 5, 2021

Study Start

December 10, 2015

Primary Completion

January 17, 2019

Study Completion

December 19, 2019

Last Updated

March 5, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share