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Clinical Trials/NCT01950858
NCT01950858
Unknown
Phase 1

Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee

Assaf-Harofeh Medical Center1 site in 1 country40 target enrollmentMay 2012
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ConditionsSpontaneous Osteonecrosis of the Knee

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Spontaneous Osteonecrosis of the Knee
Sponsor
Assaf-Harofeh Medical Center
Enrollment
40
Locations
1
Primary Endpoint
Efficacy
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
August 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Assaf Harofeh MC

Yiftah Beer

Assaf-Harofeh Medical Center

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

Outcomes

Primary Outcomes

Efficacy

Time Frame: 6 weeks

Pain Reduction

Safety

Time Frame: end of HBOT

Number of Participants with Adverse Events during HBOT

Secondary Outcomes

  • Reduction In AVN size by MRI(6 weeks)

Study Sites (1)

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