Nitrate Patch Use as Treatment of Knee AVN

Necrosis, Avascular, of Bone Clinical Trial

Official title:

the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01979666
• Other study ID #: SHEBA-12-9707-AL-CTIL
• Status: Terminated
• Phase: N/A
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: March 2024
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The pathogenesis of AVN includes a defective blood supply to the knee joint. Local nitrates induce peripheral vasodilation and may improve blood supply to the affected tissue.

This study aims to test whether the use of a nicotine patch may accelerate the healing process from AVN of the knee.

Description:

The main purpose of this study is to examine whether treatment with a local nitrate patch will improve MRI findings and clinical outcomes in patients with AVN of the knee.

This is a double-blind prospective study that will include 50 adult volunteers, randomly assigned to a "nitrate" group that will be given a nitrate patch, and a "placebo" group that will be given a placebo patch.

The following outcomes will be measured:

• MRI findings before and after the patch treatment

• Use of analgesics

• Subjective pain relief.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• adult patients (18-80 y.o)

• diagnosis of AVN according to MRI

Exclusion Criteria:

• Terminal illness

• Cognitive impairment / any condition disturbing informed concent.

• Nitrate intolerance

• Patients using Cyclic GMP inhibitiors

Related Conditions & MeSH terms

• Necrosis
• Necrosis, Avascular, of Bone
• Osteonecrosis

Intervention

Drug:
• nitrate patch
patients in the study group will get a nitrate patch
• placebo patch
control group patients will get a placebo patch

Device:
• MRI scan
MRI scan after 6 weeks of treatment

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in bone substrate edema	the area and percent of the knee which the edema involves	6 weeks
Secondary	other MRI changes	reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening	6 weeks
Secondary	analgesics use	according to the patient's self report	6 weeks
Secondary	pain severity	according to a visual analouge scale	6 weeks