Nitrate Patch Use as Treatment of Knee AVN | NCT01979666

Studies
Nitrate Patch Use as Treatment of Knee AVN

NCT01979666

Sponsor

Sheba Medical Center

Status

Terminated

Last Update Posted

Apr 2, 2024Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Necrosis, Avascular, of Bone

Interventions

nitrate patch
placebo patch
MRI scan

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Failure to recruit patients

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2019Actual

Completion Date

Jan 2019Actual

First Submitted Date

Nov 3, 2013

First Submission Date that Met QC Criteria

Nov 7, 2013

First Posted Date

Nov 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2024

Last Update Posted Date

Apr 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Experimental	the patients that will get a nitrate patch	Drug: nitrate patch Device: MRI scan
control group	Placebo Comparator	the patients that will get the placebo patch	Drug: placebo patch Device: MRI scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
nitrate patch	Drug	patients in the study group will get a nitrate patch	study group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
other MRI changes	reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening	6 weeks
analgesics use	according to the patient's self report

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
avi livneh	Sheba Medical Center	Principal Investigator
arik asman, MD	Sheba Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan			Israel

Condition Browse Module

MeSH Terms

ID	Term
D010020	Osteonecrosis

Ancestor Terms

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D009336	Necrosis
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided