Nitrate Patch Use as Treatment of Knee AVN

NCT ID: NCT01979666

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Necrosis, Avascular, of Bone

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

study group

the patients that will get a nitrate patch

Group Type EXPERIMENTAL

nitrate patch

Intervention Type DRUG

patients in the study group will get a nitrate patch

MRI scan

Intervention Type DEVICE

MRI scan after 6 weeks of treatment

control group

the patients that will get the placebo patch

Group Type PLACEBO_COMPARATOR

placebo patch

Intervention Type DRUG

control group patients will get a placebo patch

MRI scan

Intervention Type DEVICE

MRI scan after 6 weeks of treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

nitrate patch

patients in the study group will get a nitrate patch

Intervention Type DRUG

placebo patch

control group patients will get a placebo patch

Intervention Type DRUG

MRI scan

MRI scan after 6 weeks of treatment

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

placebo MRI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Prof.Avi Livneh

head of internal medicine ward F

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

avi livneh

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

arik asman, MD

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sheba Medical Center

Ramat Gan, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SHEBA-12-9707-AL-CTIL

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radiofrequency Ablation of Vascular Anomalies
NCT06803667 NOT_YET_RECRUITING NA
Bern Venous Stent Registry
NCT02433054 COMPLETED