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Completed

NCT Number: NCT02424084

Bone Microcirculation After Extracorporeal Shock Wave Therapy

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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)

Device

Extracorporeal Shock Wave Therapy

Primary outcomes

  1. Change in microcirculation (composite outcome measure)

    Time frame: Baseline and 1 minute post-dose

    • Bone blood flow [arbitrary units AU]
    • Bone blood velocity [AU]
    • Tissue oxygen saturation [%]
    • Relative postcapillary venous filling pressure [AU] (Composite outcome measure)

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Apr 22, 2015
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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