Hyperbaric Oxygen Therapy in Distal Radius Fractures: Can it Shorten Recovery Time and Increase Fracture Healing? (HBOTRadius)

Identification of Microcirculation in Distal Radius Fractures After Surgical Treatment With and Without Hyperbaric Oxygen Therapy (HBOT)

This project is meant to show wether the HBOT can fasten the recovery process after surgical treatment of distal Radius fractures. For this propose the microcirculation is measured, together with the level of pain on a visual analog scale (VAS) and the remaining force of the hand after surgery is examined. Furthermore the sonography with contrast medium which is long established for examination of organs of the parenchyma, is meant to be verified at the muscular-skeletal system in this project.

Study Overview

• Status: Suspended
• Conditions: Contrast Media; Hyperbaric Oxygen Therapy; Recovery Time; Sonography
• Intervention / Treatment: Procedure: Hyperbaric Oxygen Therapy

Detailed Description

This project investigates microcirculation in skin, muscle and bone after surgical treatment of distal Radius fracture with and without Hyperbaric Oxygen Therapy for detecting any benefit of the HBOT. In Hyperbaric Oxygen Therapy the patients breathes Oxygen from a mask in a pressure chamber with higher air pressure than normal atmospheric pressure wich is meant to increase the peripheric oxygen suppley in the healing tissue. The patients will receive 10 sessions of HBOT. The patients who are treated with HBOT are chosen randomly.

The microcirculation is measured as parameter for tissue damage and wound healing. It is registered by O2c, which works with measuring reflected lightwaves. It is strictly noninvasive and causes absolutely no pain for the patient. The measurement device consists of two small probes, which simply stick to the patient´s skin. There are 8 measurements in this study:

The first one shortly after the surgical treatment, then there will be one measuring appointment every week up to four week. Afterwards the patients hands will be measured in the 6th, 8th and 12th week after surgical treatment. In all measurements the healthy side will be measured as well for comparison. Additional the force fo both hands and the level of pain in the Visual Analogue Scale are evaluated.

Furthermore there will be a sonography with contrast medium in the first week after surgical treatment to indicate any increase of blood suppley after the HBOT and detect any wound healing complications.

Therefore this study will research on the one hand if there is a benefit to the HBOT for the often young and healthy patients of radius fractures to return earlier and more easily to their health condition. On the other hand this study is meant to establish the sonography with contrast medium as a examination method with little risks.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • RWTH Aachen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• distal radius fracture
• only one radius is fractured
• medical treatment within 72 hours after accident
• patient will receive surgical treatment (plate)
• patient received information letter and singed agreement
• patient is German-speaking
• patient is competent
• patient is over 18 years of age

Exclusion Criteria:

• pathologic fractures
• open fractures
• fractures with wide soft tissue damage, that affects surgical treatment
• surgical treatment after more than 72 hours after the accident
• diabetes mellitus, that need medical treatment
• patient has PAD
• previous surgery treatment on the fractured arm or refracture
• patient is not competent
• immune deficiency
• polytrauma
• patient with diseases of the lung (hypercapnia)
• patient with open Foramen ovale
• pregnant women
• patient with NYHA IV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: With HBOT; Patients, who receive hyperbaric Oxygen Therapy after their surgical treatment	Procedure: Hyperbaric Oxygen Therapy; The patients receive 10 sessions of HBOT in two weeks, starting on the day after the surgical treatment of their radius fracture. Each session lasts about one hour.
No Intervention: Without HBOT; Patients who receive the same surgical treatment of their radius fracture than the patients of the group "with HBOT", but no hyperbaric oxygen therapy (comparison group)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional outcome	The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.	18 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Study Chair: Hans-Christoph Pape, Univ.-Prof. MD FACS, Dpt. of Orthopedic Trauma, RWTH Aachen University

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): November 1, 2012
• Study Completion (Anticipated): November 1, 2012

Study Registration Dates

• First Submitted: June 1, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Estimate): November 28, 2012
• Last Update Submitted That Met QC Criteria: November 27, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: microcirculation, O2c
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Radius Fractures
• Other Study ID Numbers: CTC-A10-29