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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01365780
Recruitment Status : Suspended (


acceptence by patient too low

First Posted : June 3, 2011
Last Update Posted : November 28, 2012
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperbaric Oxygen Therapy Recovery Time Contrast Media Sonography Procedure: Hyperbaric Oxygen Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Identification of Microcirculation in Distal Radius Fractures After Surgical Treatment With and Without Hyperbaric Oxygen Therapy (HBOT)
Study Start Date : September 2011
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

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)

Primary Outcome Measures :
  1. functional outcome [ Time Frame: 18 months ]
    The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01365780

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RWTH Aachen University Hospital
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
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Principal Investigator: Matthias Knobe, MD Dpt. of Orthopedic Trauma, RWTH Aachen University
Study Chair: Hans-Christoph Pape, Univ.-Prof. MD FACS Dpt. of Orthopedic Trauma, RWTH Aachen University
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Responsible Party: RWTH Aachen University Identifier: NCT01365780    
Other Study ID Numbers: CTC-A10-29
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: November 28, 2012
Last Verified: November 2012
Keywords provided by RWTH Aachen University:
microcirculation, O2c
Additional relevant MeSH terms:
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Radius Fractures
Wrist Fractures
Forearm Injuries
Arm Injuries
Wounds and Injuries
Fractures, Bone
Wrist Injuries