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

Primary Purpose

Spontaneous Osteonecrosis of the Knee

Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Weight reduction
Sponsored by
Assaf-Harofeh Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spontaneous Osteonecrosis of the Knee

Eligibility Criteria

40 Months - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf-Harofeh Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biological

Control

Arm Description

6 weeks of HBO treatment as well as non weight bearing

non weight bearing

Outcomes

Primary Outcome Measures

Efficacy
Pain Reduction
Safety
Number of Participants with Adverse Events during HBOT

Secondary Outcome Measures

Reduction In AVN size by MRI

Full Information

First Posted
August 28, 2013
Last Updated
September 19, 2013
Sponsor
Assaf-Harofeh Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01950858
Brief Title
Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteonecrosis of the Knee
Official Title
Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assaf-Harofeh Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spontaneous Osteonecrosis of the Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Biological
Arm Type
Experimental
Arm Description
6 weeks of HBO treatment as well as non weight bearing
Arm Title
Control
Arm Type
Active Comparator
Arm Description
non weight bearing
Intervention Type
Biological
Intervention Name(s)
Weight reduction
Primary Outcome Measure Information:
Title
Efficacy
Description
Pain Reduction
Time Frame
6 weeks
Title
Safety
Description
Number of Participants with Adverse Events during HBOT
Time Frame
end of HBOT
Secondary Outcome Measure Information:
Title
Reduction In AVN size by MRI
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Months
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yiftah Beer, MD
Phone
972-8-9779432
Email
yiftah.beer@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shai Efrati, MD
Organizational Affiliation
Assaf-Harofeh Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Assaf-Harofeh Medical Center
City
Zerifin
ZIP/Postal Code
70300
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yiftah Beer, MD
Phone
972-8-9779432
Email
yiftah.beer@gmail.com

12. IPD Sharing Statement

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

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