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Nitrate Patch Use as Treatment of Knee AVN

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ClinicalTrials.gov Identifier: NCT01979666
Recruitment Status : Unknown
Verified October 2017 by Prof.Avi Livneh, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : November 8, 2013
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Prof.Avi Livneh, 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.


Condition or disease Intervention/treatment Phase
Necrosis, Avascular, of Bone Drug: nitrate patch Drug: placebo patch Device: MRI scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee
Study Start Date : January 2014
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2019

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 Name: MRI

Placebo Comparator: control group
the patients that will get the placebo patch
Drug: placebo patch
control group patients will get a placebo patch
Other Name: placebo

Device: MRI scan
MRI scan after 6 weeks of treatment
Other Name: MRI




Primary Outcome Measures :
  1. Reduction in bone substrate edema [ Time Frame: 6 weeks ]
    the area and percent of the knee which the edema involves


Secondary Outcome Measures :
  1. other MRI changes [ Time Frame: 6 weeks ]
    reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening

  2. analgesics use [ Time Frame: 6 weeks ]
    according to the patient's self report

  3. pain severity [ Time Frame: 6 weeks ]
    according to a visual analouge scale



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01979666


Contacts
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Contact: Avi Livneh, MD 972-3-530-2454 avi.livneh@sheba.health.gov.il
Contact: Arik Asman, MD 972-3-530-2454 arik.asman@sheba.health.gov.il

Locations
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Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel
Contact: arik asman, MD    972-3-5302454      
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: avi livneh Sheba Medical Center
Study Director: arik asman, MD Sheba Medical Center

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Responsible Party: Prof.Avi Livneh, head of internal medicine ward F, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01979666     History of Changes
Other Study ID Numbers: SHEBA-12-9707-AL-CTIL
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Keywords provided by Prof.Avi Livneh, Sheba Medical Center:
Knee AVN, Nitrates
Additional relevant MeSH terms:
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Osteonecrosis
Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases