Nitrate Patch Use as Treatment of Knee AVN

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Necrosis, Avascular, of Bone

Intervention / Treatment
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* Drug: nitrate patch
* Drug: placebo patch
* Device: MRI scan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group<br>the patients that will get a nitrate patch | Drug: nitrate patch<br>* patients in the study group will get a nitrate patch<br>Device: MRI scan<br>* MRI scan after 6 weeks of treatment<br>* Other names: MRI;|
| Placebo Comparator: control group<br>the patients that will get the placebo patch | Drug: placebo patch<br>* control group patients will get a placebo patch<br>* Other names: placebo;Device: MRI scan<br>* MRI scan after 6 weeks of treatment<br>* Other names: MRI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in bone substrate edema | the area and percent of the knee which the edema involves | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| other MRI changes | reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening | 6 weeks | 
| analgesics use | according to the patient's self report | 6 weeks | 
| pain severity | according to a visual analouge scale | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Knee AVN, Nitrates