Nitrate Patch Use as Treatment of Knee AVN
- Conditions
- Necrosis, Avascular, of Bone
- Interventions
- Registration Number
- NCT01979666
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
- adult patients (18-80 y.o)
- diagnosis of AVN according to MRI
- Terminal illness
- Cognitive impairment / any condition disturbing informed concent.
- Nitrate intolerance
- Patients using Cyclic GMP inhibitiors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control group MRI scan the patients that will get the placebo patch study group nitrate patch the patients that will get a nitrate patch study group MRI scan the patients that will get a nitrate patch control group placebo patch the patients that will get the placebo patch
- Primary Outcome Measures
Name Time Method Reduction in bone substrate edema 6 weeks the area and percent of the knee which the edema involves
- Secondary Outcome Measures
Name Time Method other MRI changes 6 weeks reduction of subchondral fracture resolution of accompanied findings presence of femoral head or condyle flattening
analgesics use 6 weeks according to the patient's self report
pain severity 6 weeks according to a visual analouge scale
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Ramat Gan, Israel