Nitrate Patch Use as Treatment of Knee AVN

Sheba Medical Center

Status: Terminated

Conditions: Necrosis, Avascular, of Bone

Treatments: Drug: nitrate patch; Device: MRI scan; Drug: placebo patch

Study type: Interventional

Funder types: Other

Identifiers

NCT01979666

SHEBA-12-9707-AL-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups, including a placebo group

study group

Experimental group

Description:

the patients that will get a nitrate patch

Treatment:

Drug: nitrate patch

Device: MRI scan

control group

Placebo Comparator group

Description:

the patients that will get the placebo patch

Treatment:

Drug: placebo patch

Device: MRI scan