Nitrate Patch Use as Treatment of Knee AVN

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01979666

Enrollment

Registered

2013-11-08

Start date

2014-01-31

Completion date

2019-01-31

Last updated

2024-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Necrosis, Avascular, of Bone

Keywords

Knee AVN, Nitrates

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.

Interventions

DRUGnitrate patch

patients in the study group will get a nitrate patch

DRUGplacebo patch

control group patients will get a placebo patch

DEVICEMRI scan

MRI scan after 6 weeks of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Reduction in bone substrate edema	6 weeks	the area and percent of the knee which the edema involves

Secondary

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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026