Hyper Baric Oxygen Therapy (HBOT) for Spontaneous Osteone... | NCT01950858

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

NCT01950858

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Sep 26, 2013Estimated

Enrollment

40Estimated

Phase

Phase 1

Conditions

Spontaneous Osteonecrosis of the Knee

Interventions

Weight reduction

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

May 2015Estimated

Completion Date

Aug 2015Estimated

First Submitted Date

Aug 28, 2013

First Submission Date that Met QC Criteria

Sep 19, 2013

First Posted Date

Sep 26, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 19, 2013

Last Update Posted Date

Sep 26, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Assaf Harofeh MC, Yiftah Beer, Assaf-Harofeh Medical CenterPrincipal Investigator

Lead Sponsor

Assaf-Harofeh Medical CenterOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biological	Experimental	6 weeks of HBO treatment as well as non weight bearing	Biological: Weight reduction
Control	Active Comparator	non weight bearing	Biological: Weight reduction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Weight reduction	Biological		Biological Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy	Pain Reduction	6 weeks
Safety	Number of Participants with Adverse Events during HBOT	end of HBOT

Secondary Outcomes

Measure	Description	Time Frame
Reduction In AVN size by MRI		6 weeks

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Months

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yiftah Beer, MD	Contact	972-8-9779432		yiftah.beer@gmail.com

Overall Officials

Name	Affiliation	Role
Shai Efrati, MD	Assaf-Harofeh Medical Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf-Harofeh Medical Center	Recruiting	Ẕerifin		70300	Israel