Bone Microcirculation After Extracorporeal Shock Wave Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2023-02-28

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.

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Detailed Description

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Conditions

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Intact Scaphoid Bone Intact Metacarpal Bone Fractured Scaphoid Bone Fractured Metacarpal Bone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Intervention Type DEVICE

Extracorporeal Shock Wave Therapy

Interventions

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Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Extracorporeal Shock Wave Therapy

Intervention Type DEVICE

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.