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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| 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) |
|
| 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) |
|
| 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) |
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| Intact metatarsal bone | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) | Device | Extracorporeal Shock Wave Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in microcirculation (composite outcome measure) |
| Baseline and 1 minute post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tobias Kisch, MD | University Hospital Schleswig-Holstein | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Schleswig-Holstein | Lübeck | Schleswig-Holstein | 23538 | Germany |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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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) |
|
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |