Bone Microcirculation After Extracorporeal Shock Wave Therapy

Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation

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 Overview

• Status: Completed
• Conditions: Intact Scaphoid Bone; Intact Metacarpal Bone; Fractured Scaphoid Bone; Fractured Metacarpal Bone
• Intervention / Treatment: Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • University of Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intact scaphoid bone; 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); Extracorporeal Shock Wave Therapy
Experimental: Intact metacarpal bone; 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); Extracorporeal Shock Wave Therapy
Experimental: Fractured scaphoid bone; 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); Extracorporeal Shock Wave Therapy
Experimental: Fractured metacarpal bone; 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); Extracorporeal Shock Wave Therapy
Experimental: Intact metatarsal bone; 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); Extracorporeal Shock Wave Therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: April 19, 2015
• First Posted (Estimate): April 22, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 14-266-4