CompletedNot Applicable

Bone Microcirculation After Extracorporeal Shock Wave Therapy

Germany80 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in microcirculation (composite outcome measure)

Timeframe: Baseline and 1 minute post-dose

Trial details

NCT IDNCT02424084

SponsorUniversity Hospital Schleswig-Holstein

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02

View on ClinicalTrials.gov More Intact Scaphoid Bone trials