Bone Microcirculation After Extracorporeal Shock Wave Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation

Conditions
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Intact Scaphoid Bone, Intact Metacarpal Bone, Fractured Scaphoid Bone, Fractured Metacarpal Bone

Intervention / Treatment
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* Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intact scaphoid bone<br>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) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy<br>|
| Experimental: Intact metacarpal bone<br>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) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy<br>|
| Experimental: Fractured scaphoid bone<br>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) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy<br>|
| Experimental: Fractured metacarpal bone<br>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) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy<br>|
| Experimental: Intact metatarsal bone<br>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) | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)<br>* Extracorporeal Shock Wave Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Baseline and 1 minute post-dose |