Bone Microcirculation After Remote Ischemic Preconditioning

NCT02554500 | Completed

• 1 other identifier: 14-266-5
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Intact Scaphoid Bone; Intact Metacarpal Bone; Fractured Scaphoid Bone; Fractured Metacarpal Bone

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (5)

Intact scaphoid bone

EXPERIMENTAL

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)

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: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Fractured scaphoid bone

EXPERIMENTAL

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)

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: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

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: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Interventions

Remote Ischemic Preconditioning (by Blood Pressure Cuff) PROCEDURE

Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.

Fractured metacarpal bone; Fractured scaphoid bone; Intact metacarpal bone; Intact metatarsal bone; Intact scaphoid bone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• below 18 years of age
• scar tissue above measuring focus
• osteoporosis or comparable bone disease
• medication that influences bones

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

University of Schleswig-Holstein

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Study Officials

• Tobias Kisch, MD

  University Hospital Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 16, 2015
• First Posted: September 18, 2015
• Study Start: September 1, 2015
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 24, 2023

Record last verified: 2023-02

Locations

DE (1)