Bone Microcirculation After Extracorporeal Shock Wave Therapy

Not Applicable

Completed

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

• Registration Number: NCT02424084
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-19
• Study First Posted: 2015-04-22
• Status Verified: 2023-02
• Primary Completion: 2023-02
• Study Completion: 2023-02
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in microcirculation (composite outcome measure)	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)

Trial Locations

Locations (1)

University of Schleswig-Holstein; 🇩🇪 Lübeck, Schleswig-Holstein, Germany