Spontaneous Osteonecrosis of the Knee Clinical Trial
Official title:
Safety and Efficacy of Hyper Baric Oxygen Therapy (HBOT) in Patients Presenting With Spontaneous Osteonecrosis of the Knee
safety and efficacy of Hyper Baric Oxygen (HBO) in patients presenting with spontaneous osteonecrosis of the knee
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Months to 85 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Assaf-Harofeh Medical Center | Zerifin |
| Lead Sponsor | Collaborator |
|---|---|
| Assaf-Harofeh Medical Center |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Efficacy | Pain Reduction | 6 weeks | No |
| Primary | Safety | Number of Participants with Adverse Events during HBOT | end of HBOT | Yes |
| Secondary | Reduction In AVN size by MRI | 6 weeks | No |