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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Assaf-Harofeh Medical Center
Sponsor:
Information provided by (Responsible Party):
Assaf Harofeh MC, Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier:
NCT01950858
First received: August 28, 2013
Last updated: September 19, 2013
Last verified: September 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Pain Reduction

  • Safety [ Time Frame: end of HBOT ] [ Designated as safety issue: Yes ]
    Number of Participants with Adverse Events during HBOT


Secondary Outcome Measures:
  • Reduction In AVN size by MRI [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Months to 85 Years
Genders Eligible for Study:   Both
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
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: 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

No publications provided

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
Study First Received: August 28, 2013
Last Updated: September 19, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on August 01, 2014