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Nitrate Patch Use as Treatment of Knee AVN

Primary Purpose

Necrosis, Avascular, of Bone

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
nitrate patch
placebo patch
MRI scan
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Necrosis, Avascular, of Bone focused on measuring Knee AVN, Nitrates

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sheba Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group

control group

Arm Description

the patients that will get a nitrate patch

the patients that will get the placebo patch

Outcomes

Primary Outcome Measures

Reduction in bone substrate edema
the area and percent of the knee which the edema involves

Secondary Outcome Measures

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

Full Information

First Posted
November 3, 2013
Last Updated
October 10, 2017
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01979666
Brief Title
Nitrate Patch Use as Treatment of Knee AVN
Official Title
the Effect of a Nitrate Patch on the Healing Process of AVN of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrosis, Avascular, of Bone
Keywords
Knee AVN, Nitrates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Experimental
Arm Description
the patients that will get a nitrate patch
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
the patients that will get the placebo patch
Intervention Type
Drug
Intervention Name(s)
nitrate patch
Intervention Description
patients in the study group will get a nitrate patch
Intervention Type
Drug
Intervention Name(s)
placebo patch
Other Intervention Name(s)
placebo
Intervention Description
control group patients will get a placebo patch
Intervention Type
Device
Intervention Name(s)
MRI scan
Other Intervention Name(s)
MRI
Intervention Description
MRI scan after 6 weeks of treatment
Primary Outcome Measure Information:
Title
Reduction in bone substrate edema
Description
the area and percent of the knee which the edema involves
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
other MRI changes
Description
reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening
Time Frame
6 weeks
Title
analgesics use
Description
according to the patient's self report
Time Frame
6 weeks
Title
pain severity
Description
according to a visual analouge scale
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Avi Livneh, MD
Phone
972-3-530-2454
Email
avi.livneh@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Arik Asman, MD
Phone
972-3-530-2454
Email
arik.asman@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
avi livneh
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
arik asman, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
arik asman, MD
Phone
972-3-5302454

12. IPD Sharing Statement

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Nitrate Patch Use as Treatment of Knee AVN

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