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.|
|ClinicalTrials.gov Identifier: NCT01365780|
Recruitment Status : Suspended (
acceptence by patient too low)
First Posted : June 3, 2011
Last Update Posted : November 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Hyperbaric Oxygen Therapy Recovery Time Contrast Media Sonography||Procedure: Hyperbaric Oxygen Therapy||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01365780
|RWTH Aachen University Hospital|
|Aachen, NRW, Germany, 52074|
|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|