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Clinical Trials/NCT01950858
NCT01950858UnknownPhase 1

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

Assaf-Harofeh Medical Center2 sites in 1 country40 target enrollmentStarted: May 2012Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
40
Locations
2
Primary Endpoint
Efficacy
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Months to 85 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Assaf Harofeh MC

Yiftah Beer

Assaf-Harofeh Medical Center

Study Sites (2)

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