Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To investigate the effect of PEMF treatment when administered twice daily over a 90-day period by looking at synovial fluid in subjects with osteoarthritis of the knee.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Provant Therapy System | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Synovial markers measured included bone morphologic proteins, related proteins Activin A, Osteoactivin, sonic hedgehog, Dickkopf, interleukin cytokines and tumor necrosis factor alpha, Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1. Inflammation related proteins assayed were monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine. Adhesion and matrix metalloproteinase proteins levels were also determined. The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6). | Baseline, Days 45 and 90 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado Orthopaedics | Lone Tree | Colorado | 80124 | United States | ||
| Spokane Joint Replacement |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Active Treatment (Provant Therapy System) | Provant Therapy System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Active Treatment | Provant Therapy System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Synovial Markers Showing a Reduction From Baseline Following Treatment at Days 45 and 90 | Synovial markers measured included bone morphologic proteins, related proteins Activin A, Osteoactivin, sonic hedgehog, Dickkopf, interleukin cytokines and tumor necrosis factor alpha, Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1. Inflammation related proteins assayed were monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine. Adhesion and matrix metalloproteinase proteins levels were also determined. The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6). | The mean protein concentration was calculated for these markers at Baseline (n=19), Day 45 (n=7) and Day 90 (n=6). | Posted | Count of Units | protein markers | Baseline, Days 45 and 90 | protein markers | protein markers |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Treatment | Provant Therapy System | 0 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased knee pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations Manager | Regenesis Biomedical | 602-428-7041 | heather.vanderploeg@regenesisbio.com |
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Spokane |
| Washington |
| 99218 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | BMP and Related Proteins | BMP and related protein synovial markers measured included 9 markers: bone morphologic proteins (BMP-2, BMP-4, BMP-6, BMP-7, BMP-9) and related proteins Activin A, Osteoactivin (Ostact), sonic hedgehog (Shh N) and Dickkopf (DKK-1). |
| OG001 | Cytokines | The 7 synovial markers measured included the levels of interleukin cytokines and tumor necrosis factor alpha (Il-1α, IL-1β, IL-6, IL-8, IL-11, IL-17 and TNFα), |
| OG002 | Growth Factors and Related Proteins | The 10 synovial markers included in this group include Growth Factors and Related Proteins fibroblast growth factors 1,2, androgen receptor, platelet derived growth factor BB, tumor growth factor beta, osteprogenerin, osteopontin, and Insulin like growth factor-1 (FGF-1, FGF-2, AR, PDGF BB, TGF b1, TGF b2, TGF b3, OPG, OPN and IGF-1 |
| OG003 | Bone Remodeling Related Proteins | The 6 synovial fluid markers in this group included monocyte chemoattractant protein-1, macrophage colony-stimulating factor, macrophage inflammatory protein, receptor activator of Nuclear factor κ, and TNF related activation induced cytokine (MCP-1, M-CSF, MIP-1a, RANK, TRANCE). |
| OG004 | Adhesion and Matrix Proteins | This group includes 4 adhesion and matrix metalloproteinase proteins: ICAM-1, P-CadH, VCAM-1, and VE-CadH. |
| OG005 | MPP Proteins | The 4 matrix metalloproteinase proteins analyzed in this group include the following: MMP-2, MMP-3, MMP-9, and MMP-13. |
|
|
| 19 |
| 0 |
| 19 |
| 10 |
| 19 |
| Increase knee swelling | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Exacerbation of patients end stage renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Anterior C6-C7 Cervical Diskectomy and Fusion with Partial Laminectomy, Medial facetectomy and foram | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Left knee buckled | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Prominent Menieres Episode | Ear and labyrinth disorders | Non-systematic Assessment |
|
Publication Rights. Independent analysis and/or publication of data generated or arising from the performance of this Agreement is not permitted without the prior written consent of Regenesis. Such consent may be contingent on Regenesis' review and approval of any proposed analysis and manuscript. Institution will retain the right to review and analyze the database created from this study for its own scientific purposes so long as such scientific purposes are non-commercial in nature.
| D012216 |
| Rheumatic Diseases |
|