Fractured Metacarpal Bone, Fractured Scaphoid Bone, Intact Metacarpal Bone, Intact Scaphoid Bone
Conditions
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.
Interventions
Extracorporeal Shock Wave Therapy
Sponsors
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Germany
Outcome results
None listed