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

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

Study Locations

      • Zerifin, Israel, 70300
        • Recruiting
        • Assaf-Harofeh Medical Center
        • Contact:

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.

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

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.

Clinical Trials on Spontaneous Osteonecrosis of the Knee

Clinical Trials on Weight reduction

3
Subscribe