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

This study has suspended participant recruitment.
(

nump

acceptence by patient too low

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Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01365780
First received: June 1, 2011
Last updated: November 27, 2012
Last verified: November 2012
  Purpose

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 Intervention
Hyperbaric Oxygen Therapy
Recovery Time
Contrast Media
Sonography
Procedure: Hyperbaric Oxygen Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Identification of Microcirculation in Distal Radius Fractures After Surgical Treatment With and Without Hyperbaric Oxygen Therapy (HBOT)

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • functional outcome [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.


Estimated Enrollment: 100
Study Start Date: September 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01365780

Locations
Germany
RWTH Aachen University Hospital
Aachen, NRW, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
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
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01365780     History of Changes
Other Study ID Numbers: CTC-A10-29
Study First Received: June 1, 2011
Last Updated: November 27, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by RWTH Aachen University:
microcirculation, O2c

Additional relevant MeSH terms:
Radius Fractures
Arm Injuries
Forearm Injuries
Fractures, Bone
Wounds and Injuries

ClinicalTrials.gov processed this record on October 30, 2014