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Nitrate Patch Use as Treatment of Knee AVN

Not Applicable
Terminated
Conditions
Necrosis, Avascular, of Bone
Interventions
Drug: nitrate patch
Drug: placebo patch
Device: MRI scan
Registration Number
NCT01979666
Lead Sponsor
Sheba Medical Center
Brief 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.

Detailed 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 & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • adult patients (18-80 y.o)
  • diagnosis of AVN according to MRI
Read More
Exclusion Criteria
  • Terminal illness
  • Cognitive impairment / any condition disturbing informed concent.
  • Nitrate intolerance
  • Patients using Cyclic GMP inhibitiors
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
control groupMRI scanthe patients that will get the placebo patch
study groupnitrate patchthe patients that will get a nitrate patch
study groupMRI scanthe patients that will get a nitrate patch
control groupplacebo patchthe patients that will get the placebo patch
Primary Outcome Measures
NameTimeMethod
Reduction in bone substrate edema6 weeks

the area and percent of the knee which the edema involves

Secondary Outcome Measures
NameTimeMethod
other MRI changes6 weeks

reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening

analgesics use6 weeks

according to the patient's self report

pain severity6 weeks

according to a visual analouge scale

Trial Locations

Locations (1)

Sheba Medical Center

🇮🇱

Ramat Gan, Israel

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