The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.

Study Overview
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Brief Summary
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The hypothesis of this study is that since osteoarthritis of the knee is primarily a bone disease where the joint changes are secondary, and bone growth stimulators function to decrease intraosseous venous congestion and remodel bone, then there is a potential benefit for the treatment of osteoarthritis of the knee with bone growth stimulators.

Detailed Description
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The hypothesis of this study is based on the knowledge that osteoarthritis of the knee is primarily a bone disease, and the joint changes are secondary. Bone growth stimulators function to alleviate intraosseous venous congestion through the process of bone remodeling. The working hypothesis is that alleviation of intraosseous venous congestion leads to improved delivery of nutrition to the tissue to support the health of the bone with improvement in biomechanics leading to clinical improvement. Venous congestion is measured with intraosseous pressure. Additional objective evidence of biomarkers of bone metabolism as well as measurements of subjective questionnaires can provide evidence of benefit.

Official Title
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The Use of Bone Growth Stimulators for Osteoarthritis of the Knee.

Conditions
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Osteo Arthritis Knee

Intervention / Treatment
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* Device: Ultrasound Bone Growth Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have diagnosis of osteoarthritis of the knee with radiographic evidence of joint space narrowing, Kellgren-Lawrence Classification grade Grade 3 or 4. Subjects must discontinue corticosteroids administered by any route except intranasal spray, steroid- containing ophthalmic solutions and anti-asthmatics. Subjects must speak English. Subject must be willing and able to sign an informed consent document. Subjects must be willing and able to comply with all study procedures for the duration of the clinical study. Exclusion Criteria: Subjects with a diagnosis of inflammatory arthritis such as rheumatoid arthritis, gout, joint infection, Lyme disease, or systemic lupus erythematosus. Subjects with a diagnosis of secondary arthritis such as acromegaly, Charcot's arthropathy, hemochromatosis, or Wilson's disease. Subjects who have had an injury to the index knee within 6 months of starting treatment. Subjects must NOT have had arthroscopy within 8 weeks of starting treatment. Subjects must NOT have had viscosupplementation within 8 weeks of starting treatment. Subjects who plan to have surgery on the target knee within the study period. Subjects with surgical metallic hardware in the target knee. Subjects who are unwilling or unable to adhere to the follow up schedule and procedures. Subjects who are pregnant.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Participants use active Ultrasound Bone Growth Stimulator device according to Investigational Protocol. | Device: Ultrasound Bone Growth Stimulator<br>* Active device emits ultrasound signals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraosseous Venous Congestion measured by Intraossous Pressure. | Statistically significant decrease in intraosseous pressure following treatment. | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Matrix Metalloproteinase-3 (MMP-3) | Statistically significant decrease in the biomarker MMP-3 | 14 weeks | 
| C- telopeptide. | Statistically significant decrease in the biomarker C- telopeptide. | 14 weeks | 
| Change over time in WOMAC score. | The primary outcome variables are a statistically significant improvement in Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores. | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis, Knee, Bone Growth Stimulators, Rheumatic Diseases, Musculoskeletal Diseases, Joint Diseases, Arthritis