Back to resultsBone Microcirculation After Remote Ischemic Preconditioning
Primary Purpose
Intact Scaphoid Bone, Intact Metacarpal Bone, Fractured Scaphoid Bone
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Sponsored by
About this trial
This is an interventional basic science trial for Intact Scaphoid Bone
Eligibility Criteria
Inclusion Criteria:
- Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone.
- 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 bone.
- 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 measuring focus
- osteoporosis or comparable bone disease
- medication that influences bones
Sites / Locations
- University of Schleswig-Holstein
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Intact scaphoid bone
Intact metacarpal bone
Fractured scaphoid bone
Fractured metacarpal bone
Intact metatarsal bone
Arm Description
Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone. Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone. Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid bone. Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone. Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metatarsal bone. Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT02554500
First Posted
September 16, 2015
Last Updated
February 22, 2023
Sponsor
University Hospital Schleswig-Holstein
1. Study Identification
Unique Protocol Identification Number
NCT02554500
Brief Title
Bone Microcirculation After Remote Ischemic Preconditioning
Official Title
Effects of Remote Ischemic Preconditioning in Bone Microcirculation
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 2023 (Actual)
Study Completion Date
February 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 remote ischemic preconditioning (RIPC) 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 remote ischemic preconditioning (RIPC) on scaphoid bones and metacarpal bones and metatarsal bones in a human in-vivo setting for the first time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intact Scaphoid Bone, Intact Metacarpal Bone, Fractured Scaphoid Bone, Fractured Metacarpal Bone
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intact scaphoid bone
Arm Type
Experimental
Arm Description
Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone.
Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Arm Title
Intact metacarpal bone
Arm Type
Experimental
Arm Description
Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metacarpal bone.
Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Arm Title
Fractured scaphoid bone
Arm Type
Experimental
Arm Description
Group C (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured scaphoid bone.
Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Arm Title
Fractured metacarpal bone
Arm Type
Experimental
Arm Description
Group D (n=20): Consent-capable male and female patients ≥18 years of age who have a fractured metacarpal bone.
Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Arm Title
Intact metatarsal bone
Arm Type
Experimental
Arm Description
Group B (n=20): Consent-capable male and female patients ≥18 years of age who have an intact metatarsal bone.
Intervention: Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Intervention Type
Procedure
Intervention Name(s)
Remote Ischemic Preconditioning (by Blood Pressure Cuff)
Intervention Description
Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Primary Outcome Measure Information:
Title
Change in microcirculation (composite outcome measure)
Description
Bone blood flow [arbitrary units AU]
Bone blood velocity [AU]
Tissue oxygen saturation [%]
Relative postcapillary venous filling pressure [AU] (Composite outcome measure)
Time Frame
Baseline and 1 minute post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Group A (n=20): Consent-capable male and female patients ≥18 years of age who have an intact scaphoid bone.
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 bone.
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 measuring focus
osteoporosis or comparable bone disease
medication that influences bones
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tobias Kisch, MD
Organizational Affiliation
University Hospital Schleswig-Holstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Schleswig-Holstein
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Bone Microcirculation After Remote Ischemic Preconditioning
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