Intact Scaphoid BoneNCT02424084
Bone Microcirculation After Extracorporeal Shock Wave Therapy
A study testing Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) in people with Intact Scaphoid Bone and Intact Metacarpal Bone, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intact Scaphoid Bone, Intact Metacarpal Bone, Fractured Scaphoid Bone
- What is being tested?
- Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- below 18 years of age
- scar tissue above scaphoid or metacarpal bone
- osteoporosis or comparable bone disease
- medication that influences bones
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Schleswig-Holstein
Lübeck, Schleswig-Holstein, 23538
About this study
Official title: Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation
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
- Being tested
- Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)Device
Extracorporeal Shock Wave Therapy
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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) Receives: Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 1 minute post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2023
- Study completionFeb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intact Scaphoid BoneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tobias Kisch, University Hospital Schleswig-Holstein
- Investigators
- Tobias Kisch, MD, Principal investigator, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424084
- Sponsor's protocol ID
- 14-266-4
- Status last verified
- Feb 2023
- First submitted
- 31 Mar 2015
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Extracorporeal Shock Wave Therapy in Bone Microcirculation
- ClinicalTrials.gov ID
- NCT02424084
- Acronym / sponsor ID
- 14-266-4
- Conditions
- Intact Scaphoid Bone, Intact Metacarpal Bone, Fractured Scaphoid Bone, Fractured Metacarpal Bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2023 (actual)
- Study completion
- Feb 2023 (actual)
- First posted
- 22 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Intact scaphoid bone | Experimental | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)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) |
| Intact metacarpal bone | Experimental | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)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 | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)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 | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)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) |
| Intact metatarsal bone | Experimental | Device: Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- below 18 years of age
- scar tissue above scaphoid or metacarpal bone
- osteoporosis or comparable bone disease
- medication that influences bones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)Extracorporeal Shock Wave Therapy | Device | Fractured metacarpal bone, Fractured scaphoid bone, Intact metacarpal bone, Intact metatarsal bone, Intact scaphoid bone |
Primary outcome
Change in microcirculation (composite outcome measure)
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Kisch, MD principal investigator
University Hospital Schleswig-Holstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy (Device Name: PiezoWave) in people with Intact Scaphoid Bone and Intact Metacarpal Bone, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in microcirculation (composite outcome measure) (time frame: Baseline and 1 minute post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.