Hyperbaric Oxygen TherapyHBOTRadiusNCT01365780
Hyperbaric Oxygen Therapy in Distal Radius Fractures: Can it Shorten Recovery Time and Increase Fracture Healing?
A study testing Hyperbaric Oxygen Therapy in people with Hyperbaric Oxygen Therapy and Recovery Time, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperbaric Oxygen Therapy, Recovery Time, Contrast Media
- What is being tested?
- Hyperbaric Oxygen Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperbaric Oxygen Therapy, Recovery Time, Contrast Media, Sonography
- Being tested
- Hyperbaric Oxygen Therapy
- Keywords
- microcirculation, O2c
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbaric Oxygen TherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| With HBOT | Active comparator | Patients, who receive hyperbaric Oxygen Therapy after their surgical treatment Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
functional outcome
The functional outcome is measured by microcirculation as parameter for wound healing, force of the treated hand and level of pain.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (estimated)
Why it stopped: nump acceptence by patient too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperbaric Oxygen TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Knobe, MD, Principal investigator, Dpt. of Orthopedic Trauma, RWTH Aachen UniversityHans-Christoph Pape, Univ.-Prof. MD FACS, Study chair, Dpt. of Orthopedic Trauma, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01365780
- Sponsor's protocol ID
- CTC-A10-29
- Acronym
- HBOTRadius
- Status last verified
- Nov 2012
- First submitted
- 1 Jun 2011
- Last updated
- 28 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Microcirculation in Distal Radius Fractures After Surgical Treatment With and Without Hyperbaric Oxygen Therapy (HBOT)
- ClinicalTrials.gov ID
- NCT01365780
- Acronym / sponsor ID
- HBOTRadius / CTC-A10-29
- Conditions
- Hyperbaric Oxygen Therapy, Recovery Time, Contrast Media, Sonography
- Keywords
- microcirculation, O2c
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: nump acceptence by patient too low
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 3 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With HBOT | Active comparator | Procedure: Hyperbaric Oxygen TherapyPatients, who receive hyperbaric Oxygen Therapy after their surgical treatment |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbaric Oxygen TherapyThe 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. | Procedure or surgery | With HBOT |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Knobe, MD principal investigator
Dpt. of Orthopedic Trauma, RWTH Aachen University
Hans-Christoph Pape, Univ.-Prof. MD FACS study chair
Dpt. of Orthopedic Trauma, RWTH Aachen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperbaric Oxygen Therapy in people with Hyperbaric Oxygen Therapy and Recovery Time, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 28 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional outcome (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2012.