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For safety concerns
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The purpose of this study is to determine whether Agilus is safe and effective in the treatment of mild to moderate ankle osteoarthritis.
The objective of this study is to compare the safety and effectiveness of Agilus to a saline injection (control) in the treatment of mild to moderate ankle osteoarthritis. This is a multi-center, randomized, double blind, saline controlled, prospective study with two (2) treatment groups. The active group will receive one injection of Agilus per week for three consecutive weeks for a total of three injections. The control group will receive one injection of normal saline per week for three consecutive weeks for a total of three injections. Follow up visits will occur at 4 weeks, 12 weeks and 26 weeks following the third injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | Agilus (Hyaluronic Acid) |
|
| Control | Placebo Comparator | Normal Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Agilus | Device | Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain. | At 4, 12 and 26 weeks post 3rd injection |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis. | At 4, 12 and 26 weeks post 3rd injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Baumhauer, MD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Associates of Hartford | Farmington | Connecticut | 06032 | United States | ||
| Pinnacle Research |
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participants were not randomized and did not receive any intervention
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Agilus (Hyaluronic Acid) Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Normal saline | Device | Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks. |
|
| Royal Palm Beach |
| Florida |
| 33411 |
| United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Institute For Foot and Ankle Reconstruction At Mercy | Baltimore | Maryland | 21202 | United States |
| Greater Chesapeake Orthopaedic Association | Baltimore | Maryland | 21218 | United States |
| Brigham Foot and Ankle Center | Boston | Massachusetts | 02115 | United States |
| Orthopedic Associates of Grand Rapids | Grand Rapids | Michigan | 49525 | United States |
| Minnesota Sports Medicine | Eden Prairie | Minnesota | 55344 | United States |
| University of Missouri | Columbia | Missouri | 65212 | United States |
| Desert Orthopaedic Center | Las Vegas | Nevada | 89121 | United States |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| UMDNJ | Newark | New Jersey | 07101 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Orthocarolina | Charlotte | North Carolina | 28203 | United States |
| Orthopedic Foot and Ankle Center | Columbus | Ohio | 43231 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19106 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Bone and Joint Clinic Houston | Houston | Texas | 77030 | United States |
| University of Texas Health Science Center At Houston | Houston | Texas | 77030 | United States |
Normal Saline
Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks.
| COMPLETED |
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| NOT COMPLETED |
|
Zero patients were analyzed for this study due to the study being closed 2 months after it started. Baseline data were not collected
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Agilus (Hyaluronic Acid) Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks. |
| BG001 | Control | Normal Saline Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
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| Age, Continuous | |||||||||||||||||||||||
| Sex: Female, Male |
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| Region of Enrollment | participants |
|
| 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 | The Comparison Between the Agilus Injection and the Saline Control Injection Groups in the Proportion of Subjects Experiencing a Reduction in the Assessment of Pain Determined by the AOS Subscale for Pain. | Zero patients were analyzed for this study due to the study being closed 2 months after it started. Data were not collected | Posted | At 4, 12 and 26 weeks post 3rd injection |
|
| |||||||||||||||||||||||
| Secondary | Secondary Effectiveness Parameters That Will be Evaluated Include the Following That Evaluate Pain, Function, Subject's Global Assessment, Quality of Life and an Individual Subject Responder Analysis. | Not Posted | At 4, 12 and 26 weeks post 3rd injection | Participants |
2 months (study was closed prior to any data being collected)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active | Agilus (Hyaluronic Acid) Agilus: Hyaluronic acid (Agilus)given by an intra-articular injection into the ankle for a total of 3 injections for 3 consecutive weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | Control | Normal Saline Normal saline: Normal Saline given by an intra-operative injection into the ankle for a total of 3 injections for 3 consecutive weeks. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical Operations | Cartiva, Inc | 770-754-3805 | rtownsend@cartiva.net |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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