Bone Microcirculation After Remote Ischemic Preconditioning

University Hospital Schleswig-Holstein (UKSH)

Status: Completed

Conditions: Intact Metacarpal Bone; Fractured Scaphoid Bone; Intact Scaphoid Bone; Fractured Metacarpal Bone

Treatments: Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Study type: Interventional

Funder types: Other

Identifiers

NCT02554500

14-266-5

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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80 participants in 5 patient groups

Intact scaphoid bone

Experimental group

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)

Treatment:

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Intact metacarpal bone

Experimental group

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)

Treatment:

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Fractured scaphoid bone

Experimental group

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)

Treatment:

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Fractured metacarpal bone

Experimental group

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)

Treatment:

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)

Intact metatarsal bone

Experimental group

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)

Treatment:

Procedure: Remote Ischemic Preconditioning (by Blood Pressure Cuff)