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Bone Microcirculation After Extracorporeal Shock Wave Therapy

Primary Purpose

Intact Scaphoid Bone, Intact Metacarpal Bone, Fractured Scaphoid Bone

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Intact Scaphoid Bone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid.
  • Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
  • Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid.
  • Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.

Exclusion Criteria:

  • below 18 years of age
  • scar tissue above scaphoid or metacarpal bone
  • osteoporosis or comparable bone disease
  • medication that influences bones

Sites / Locations

  • University of Schleswig-Holstein

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Intact scaphoid bone

Intact metacarpal bone

Fractured scaphoid bone

Fractured metacarpal bone

Intact metatarsal bone

Arm Description

Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metatarsal bone. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Outcomes

Primary Outcome Measures

Change in microcirculation (composite outcome measure)
Bone blood flow [arbitrary units AU] Bone blood velocity [AU] Tissue oxygen saturation [%] Relative postcapillary venous filling pressure [AU] (Composite outcome measure)

Secondary Outcome Measures

Full Information

First Posted
March 31, 2015
Last Updated
February 22, 2023
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT02424084
Brief Title
Bone Microcirculation After Extracorporeal Shock Wave Therapy
Official Title
Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
February 2023 (Actual)
Study Completion Date
February 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In trauma surgery and hand surgery treatment strategies of none healing bone fractures aim at replacing pseudarthrosis by well vascularized bone and improving microcirculation. Although previous studies indicate that extracorporeal shock wave therapy (ESWT) can accelerate bone healing in case of non-union, only a few studies focused on the elucidation of its mechanisms of action. Therefore, the aim of this study is to evaluate the microcirculatory effects of extracorporeal shock wave therapy on scaphoid bones and metacarpal and metatarsal in a human in-vivo setting for the first time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intact Scaphoid Bone, Intact Metacarpal Bone, Fractured Scaphoid Bone, Fractured Metacarpal Bone

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intact scaphoid bone
Arm Type
Experimental
Arm Description
Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Arm Title
Intact metacarpal bone
Arm Type
Experimental
Arm Description
Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Arm Title
Fractured scaphoid bone
Arm Type
Experimental
Arm Description
Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Arm Title
Fractured metacarpal bone
Arm Type
Experimental
Arm Description
Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Arm Title
Intact metatarsal bone
Arm Type
Experimental
Arm Description
Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metatarsal bone. Intervention: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
Intervention Description
Extracorporeal Shock Wave Therapy
Primary Outcome Measure Information:
Title
Change in microcirculation (composite outcome measure)
Description
Bone blood flow [arbitrary units AU] Bone blood velocity [AU] Tissue oxygen saturation [%] Relative postcapillary venous filling pressure [AU] (Composite outcome measure)
Time Frame
Baseline and 1 minute post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid. Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone. Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid. Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone. Exclusion Criteria: below 18 years of age scar tissue above scaphoid or metacarpal bone osteoporosis or comparable bone disease medication that influences bones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kisch, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Schleswig-Holstein
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany

12. IPD Sharing Statement

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Bone Microcirculation After Extracorporeal Shock Wave Therapy

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