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

NCT01365780 | Suspended

• 1 other identifier: CTC-A10-29
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbaric Oxygen Therapy; Recovery Time; Contrast Media; Sonography

Keywords

microcirculation, O2c

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

With HBOT

ACTIVE COMPARATOR

Patients, who receive hyperbaric Oxygen Therapy after their surgical treatment

Procedure: Hyperbaric Oxygen Therapy

Without HBOT

NO INTERVENTION

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)

Interventions

Hyperbaric Oxygen Therapy PROCEDURE

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.

With HBOT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

RWTH Aachen University Hospital

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Interventions

Hyperbaric Oxygenation

Intervention Hierarchy (Ancestors)

Oxygen Inhalation Therapy; Respiratory Therapy; Therapeutics

Study Officials

• Matthias Knobe, MD

  Dpt. of Orthopedic Trauma, RWTH Aachen University

  PRINCIPAL INVESTIGATOR

• Hans-Christoph Pape, Univ.-Prof. MD FACS

  Dpt. of Orthopedic Trauma, RWTH Aachen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2011
• First Posted: June 3, 2011
• Study Start: September 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: November 28, 2012

Record last verified: 2012-11

Locations

DE (1)