Bone Microcirculation After Extracorporeal Shock Wave Therapy

University Hospital Schleswig-Holstein80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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)

Time frame: Baseline and 1 minute post-dose