Bone Microcirculation After Extracorporeal Shock Wave Therapy

NCT02424084 | Completed

• 1 other identifier: 14-266-4
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Intact scaphoid bone

EXPERIMENTAL

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)

Intact metacarpal bone

EXPERIMENTAL

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)

Fractured scaphoid bone

EXPERIMENTAL

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)

Fractured metacarpal bone

EXPERIMENTAL

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)

Intact metatarsal bone

EXPERIMENTAL

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)

Interventions

Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) DEVICE

Extracorporeal Shock Wave Therapy

Fractured metacarpal bone; Fractured scaphoid bone; Intact metacarpal bone; Intact metatarsal bone; Intact scaphoid bone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• below 18 years of age
• scar tissue above scaphoid or metacarpal bone
• osteoporosis or comparable bone disease
• medication that influences bones

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Tobias Kisch, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 31, 2015
• First Posted: April 22, 2015
• Study Start: March 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

DE (1)