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

Phase 1

• Conditions: Spontaneous Osteonecrosis of the Knee
• Interventions: Biological: Weight reduction

• Registration Number: NCT01950858
• Lead Sponsor: Assaf-Harofeh Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-08-28
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-19
• Last Update Submitted: 2013-09-19
• Study First Posted: 2013-09-26
• Last Update Posted: 2013-09-26
• Primary Completion: 2015-05
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biological	Weight reduction	6 weeks of HBO treatment as well as non weight bearing
Control	Weight reduction	non weight bearing

Primary Outcome Measures

Name	Time	Method
Efficacy	6 weeks	Pain Reduction
Safety	end of HBOT	Number of Participants with Adverse Events during HBOT

Secondary Outcome Measures

Name	Time	Method
Reduction In AVN size by MRI	6 weeks

Trial Locations

Locations (1)

Assaf-Harofeh Medical Center; 🇮🇱 Zerifin, Israel