NCT01950858

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2012

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2013

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 26, 2013

Status Verified

September 1, 2013

Enrollment Period

3 years

First QC Date

August 28, 2013

Last Update Submit

September 19, 2013

Conditions

Spontaneous Osteonecrosis of the Knee

Outcome Measures

Primary Outcomes (2)

  • Efficacy

    Pain Reduction

    6 weeks

  • Safety

    Number of Participants with Adverse Events during HBOT

    end of HBOT

Secondary Outcomes (1)

  • Reduction In AVN size by MRI

    6 weeks

Study Arms (2)

Biological

EXPERIMENTAL

6 weeks of HBO treatment as well as non weight bearing

Biological: Weight reduction

Control

ACTIVE COMPARATOR

non weight bearing

Biological: Weight reduction

Interventions

Weight reductionBIOLOGICAL
BiologicalControl

Eligibility Criteria

Age40 Months - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age40-85 years
  • Diagnosis of Spontaneous osteonecrosis of the knee (SONK)in last month, Stage 1 or 2 by MRI.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf-Harofeh Medical Center

Ẕerifin, 70300, Israel

RECRUITING

Study Officials

  • Shai Efrati, MD

    Assaf-Harofeh Medical Center

    STUDY CHAIR

Central Study Contacts

Yiftah Beer, MD

CONTACT

972-8-9779432yiftah.beer@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yiftah Beer

Study Record Dates

First Submitted

August 28, 2013

First Posted

September 26, 2013

Study Start

May 1, 2012

Primary Completion

May 1, 2015

Study Completion

August 1, 2015

Last Updated

September 26, 2013

Record last verified: 2013-09

Locations

IL(1)