CClinicalTrials.gg
Status unknownNCT01950858Updated Sep 26, 2013

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

A Phase 1 interventional study of Weight reduction in Spontaneous Osteonecrosis of the Knee, sponsored by Assaf-Harofeh Medical Center. Status unknown at 1 site in Israel. Open to participants aged 40 Months to 85 Years. Per ClinicalTrials.gov, last updated 2013-09-26.

Sponsored by Assaf-Harofeh Medical Center · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
40 Months to 85 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Spontaneous Osteonecrosis of the Knee

Browse trials for

03

In context

Osteonecrosis

182 studies on the registry are indexed under Osteonecrosis; 31 are open to participants now.

This study's planned enrollment of 40 is below the median of 51 across 96 interventional studies indexed under Osteonecrosis.

Browse Osteonecrosis studies →

Lead sponsor

Assaf-Harofeh Medical Center is the lead sponsor of 258 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Months to 85 Years
Sexes eligible
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

Exclusion Criteria:

  • Hyperbaric treatment (HBOT) in the last 2 years.
  • Any contraindication for HBOT
  • Pregnancy.
  • Inability to sign inform consent
  • Any contraindication for MRI
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Biological

    6 weeks of HBO treatment as well as non weight bearing

    Biological: Weight reduction

  • Active comparator
    Control

    non weight bearing

    Biological: Weight reduction

Interventions

  • BiologicalWeight reduction
06

What researchers measure

Primary outcomes

  1. Efficacy

    Pain Reduction

    Time frame: 6 weeks

  2. Safety

    Number of Participants with Adverse Events during HBOT

    Time frame: end of HBOT

Secondary outcomes

  1. Reduction In AVN size by MRI

    Time frame: 6 weeks

07

Study locations

1 of 1 sites recruiting
  • Assaf-Harofeh Medical Center
    Zerifin, 70300, Israel
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01950858
Lead sponsor
Assaf-Harofeh Medical Center
Responsible party
Assaf Harofeh MC (Yiftah Beer, Assaf-Harofeh Medical Center) — Principal investigator
First posted
Sep 26, 2013
Start date
May 2012
Primary completion
May 2015 (estimated)
Completion
Aug 2015 (estimated)
Last update
Sep 26, 2013

Study contacts

Yiftah Beer, MD
Contact
yiftah.beer@gmail.com
972-8-9779432
Shai Efrati, MD
study chair · Assaf-Harofeh Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion