- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01950858
Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee
September 19, 2013 updated by: Assaf Harofeh MC, Assaf-Harofeh Medical Center
Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yiftah Beer, MD
- Phone Number: 972-8-9779432
- Email: yiftah.beer@gmail.com
Study Locations
-
-
-
Zerifin, Israel, 70300
- Recruiting
- Assaf-Harofeh Medical Center
-
Contact:
- Yiftah Beer, MD
- Phone Number: 972-8-9779432
- Email: yiftah.beer@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age40-85 years
- Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.
Exclusion Criteria:
- Hyperbaric treatment (HBOT) in the last 2 years.
- Any contraindication for HBOT
- Pregnancy.
- Inability to sign inform consent
- Any contraindication for MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Biological
6 weeks of HBO treatment as well as non weight bearing
|
|
Active Comparator: Control
non weight bearing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: 6 weeks
|
Pain Reduction
|
6 weeks
|
Safety
Time Frame: end of HBOT
|
Number of Participants with Adverse Events during HBOT
|
end of HBOT
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction In AVN size by MRI
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Shai Efrati, MD, Assaf-Harofeh Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Anticipated)
May 1, 2015
Study Completion (Anticipated)
August 1, 2015
Study Registration Dates
First Submitted
August 28, 2013
First Submitted That Met QC Criteria
September 19, 2013
First Posted (Estimate)
September 26, 2013
Study Record Updates
Last Update Posted (Estimate)
September 26, 2013
Last Update Submitted That Met QC Criteria
September 19, 2013
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91/12*1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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