Nitrate Patch Use as Treatment of Knee AVN

March 31, 2024 updated by: Prof.Avi Livneh, Sheba Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Ramat Gan, Israel
        • Sheba Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: study group
the patients that will get a nitrate patch
Drug: nitrate patch
patients in the study group will get a nitrate patch
Device: MRI scan
MRI scan after 6 weeks of treatment
Other Names:
  • MRI
Placebo Comparator: control group
the patients that will get the placebo patch
Device: MRI scan
MRI scan after 6 weeks of treatment
Other Names:
  • MRI
Drug: placebo patch
control group patients will get a placebo patch
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in bone substrate edema
Time Frame: 6 weeks
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
Time Frame: 6 weeks
reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening
6 weeks
analgesics use
Time Frame: 6 weeks
according to the patient's self report
6 weeks
pain severity
Time Frame: 6 weeks
according to a visual analouge scale
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: avi livneh, Sheba Medical Center
  • Study Director: arik asman, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

November 3, 2013

First Submitted That Met QC Criteria

November 7, 2013

First Posted (Estimated)

November 8, 2013

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 31, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-12-9707-AL-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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