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

NCT ID: NCT01950858

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-08-31

Brief Summary

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

Detailed Description

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Conditions

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Spontaneous Osteonecrosis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Biological

6 weeks of HBO treatment as well as non weight bearing

Group Type EXPERIMENTAL

Weight reduction

Intervention Type BIOLOGICAL

Control

non weight bearing

Group Type ACTIVE_COMPARATOR

Weight reduction

Intervention Type BIOLOGICAL

Interventions

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Weight reduction

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

40 Months

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Assaf Harofeh MC

Yiftah Beer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Shai Efrati, MD

Role: STUDY_CHAIR

Assaf-Harofeh Medical Center

Locations

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Assaf-Harofeh Medical Center

Ẕerifin, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Yiftah Beer, MD

Role: CONTACT

Phone: 972-8-9779432

Email: [email protected]

Facility Contacts

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Yiftah Beer, MD

Role: primary

Other Identifiers

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91/12*1

Identifier Type: -

Identifier Source: org_study_id