Bone Microcirculation After Remote Ischemic Preconditioning

Effects of Remote Ischemic Preconditioning 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 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.

Study Overview

• Status: Completed
• Conditions: Intact Scaphoid Bone; Intact Metacarpal Bone; Fractured Scaphoid Bone; Fractured Metacarpal Bone
• Intervention / Treatment: Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • University of Schleswig-Holstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intact scaphoid bone; 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)	Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff); Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Intact metacarpal bone; 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)	Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff); Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Fractured scaphoid bone; 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)	Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff); Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Fractured metacarpal bone; 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)	Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff); Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
Experimental: Intact metatarsal bone; 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)	Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff); Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline and 1 minute post-dose

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone
• Other Study ID Numbers: 14-266-5