Trial record 10 of 43 for:    Open Studies | "Osteonecrosis"

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

This study is currently recruiting participants.
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
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 April 17, 2014