Bone Microcirculation After Extracorporeal Shock Wave Therapy

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Intact Metacarpal Bone; Fractured Scaphoid Bone; Intact Scaphoid Bone; Fractured Metacarpal Bone

Treatments: Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Study type: Interventional

Funder types: Other

Identifiers

NCT02424084

14-266-4

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 5 patient groups

Intact scaphoid bone

Experimental group

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intact metacarpal bone

Experimental group

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Fractured scaphoid bone

Experimental group

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Fractured metacarpal bone

Experimental group

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Intact metatarsal bone

Experimental group

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)

Treatment:

Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)