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Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by Assaf Harofeh MC, Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01950858
First Posted: September 26, 2013
Last Update Posted: September 26, 2013
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.
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center
  Purpose
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee

Condition Intervention Phase
Spontaneous Osteonecrosis of the Knee Biological: Weight reduction Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee

Resource links provided by NLM:


Further study details as provided by Assaf Harofeh MC, Assaf-Harofeh Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 6 weeks ]
    Pain Reduction

  • Safety [ Time Frame: end of HBOT ]
    Number of Participants with Adverse Events during HBOT


Secondary Outcome Measures:
  • Reduction In AVN size by MRI [ Time Frame: 6 weeks ]

Estimated Enrollment: 40
Study Start Date: May 2012
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biological
6 weeks of HBO treatment as well as non weight bearing
Biological: Weight reduction
Active Comparator: Control
non weight bearing
Biological: Weight reduction

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Months to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01950858


Contacts
Contact: Yiftah Beer, MD 972-8-9779432 yiftah.beer@gmail.com

Locations
Israel
Assaf-Harofeh Medical Center Recruiting
Zerifin, Israel, 70300
Contact: Yiftah Beer, MD    972-8-9779432    yiftah.beer@gmail.com   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Study Chair: Shai Efrati, MD Assaf-Harofeh Medical Center
  More Information

Responsible Party: Assaf Harofeh MC, Yiftah Beer, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT01950858     History of Changes
Other Study ID Numbers: 91/12*1
First Submitted: August 28, 2013
First Posted: September 26, 2013
Last Update Posted: September 26, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Osteonecrosis
Bone Diseases
Musculoskeletal Diseases
Necrosis
Pathologic Processes