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

Shamir Medical Center (Assaf-Harofeh)

Status and phase: Unknown; Phase 1

Conditions: Spontaneous Osteonecrosis of the Knee

Treatments: Biological: Weight reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT01950858

91/12*1

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 40 months to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Biological

Experimental group

Description:

6 weeks of HBO treatment as well as non weight bearing

Treatment:

Biological: Weight reduction

Control

Active Comparator group

Description:

non weight bearing

Treatment:

Biological: Weight reduction