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Purpose: The purpose of this study is to demonstrate if the intra-articular injection of a new viscoelastic Hydrogel (Hymovis) is superior to Placebo (phosphate buffered saline [PBS] in subjects with symptomatic osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hymovis Viscoelastic Hydrogel | Active Comparator | Intra-articular Injection |
|
| Placebo | Placebo Comparator | Phosphate Buffered Saline Intra-articular Injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hymovis Intra-articular Injection | Device | Hymovis Intra-articular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain sub-score | WOMAC A Pain sub-score | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Responder Analysis | Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International (OMERACT-OARSI) Criteria | 26 weeks |
| WOMAC Function | WOMAC C Function sub-score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cynthia Secchieri, PhD | Fidia Farmceutici S.p.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Achieve Clinical Research, LLC | Birmingham | Alabama | United States | |||
| Tucson Orthopaedic Institute |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 18, 2021 | |
| Reset | Nov 15, 2021 | |
| Release | May 16, 2022 |
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| Phosphate Buffered Saline Injection | Procedure | Placebo Intra-articular injection |
|
|
| 26 Weeks |
| Visual Analog Scale (VAS) WOMAC Pain | Question A1 of WOMAC Pain sub-score | 26 Weeks |
| WOMAC Global Score | 26 Weeks |
| WOMAC Stiffness sub-score | WOMAC C stiffness sub-score | 26 Weeks |
| Rescue Medication Usage Pill Count, Failure Outcome | 26 Weeks |
| Patient Global Analysis | 26 Weeks |
| Clinician Responder Analysis | 26 Weeks |
| SF Health Outcome | 26 Weeks |
| Tucson |
| Arizona |
| United States |
| Core Orthopaedic | Encinitas | California | United States |
| San Diego Clinical Trials | San Diego | California | United States |
| Norwalk Medical Group | Norwalk | Connecticut | United States |
| Stamford Therapeutics Consortium | Stamford | Connecticut | United States |
| Tampa Bay Medical Research | Clearwater | Florida | United States |
| Homestead Clinical Research | Cutler Bay | Florida | United States |
| SJS Clinical Research | DeFuniak Springs | Florida | United States |
| Avail Clinical Research | DeLand | Florida | United States |
| Riverside Clinical Research | Edgewater | Florida | United States |
| The Andrews Institute | Gulf Breeze | Florida | United States |
| Sun Coast Clinical Research | New Port Richey | Florida | United States |
| Pensacola Research Consultants | Pensacola | Florida | United States |
| Lakeview Medical Research | Summerfield | Florida | United States |
| Drug Studies America | Marietta | Georgia | United States |
| Better Health Clinical Research | Newnan | Georgia | United States |
| Sonora Clinical Research | Boise | Idaho | United States |
| Rush University | Chicago | Illinois | United States |
| Benchmark Research | Metairie | Louisiana | United States |
| UMass Memorial Medical Center | Worcester | Massachusetts | United States |
| Shores Rheumatology | Saint Clair Shores | Michigan | United States |
| Columbus Clinical Research | Columbus | Ohio | United States |
| Radiant Research | Columbus | Ohio | United States |
| Blair Orthopedics Associates & Sports Medicine | Altoona | Pennsylvania | United States |
| Altoona Center for Clinical Research | Duncansville | Pennsylvania | United States |
| University Orthopedic Center | State College | Pennsylvania | United States |
| Radiant Research | Anderson | South Carolina | United States |
| Radiant Research | Greer | South Carolina | United States |
| Tekton Research | Austin | Texas | United States |
| Martin Diagnostic Center | Tomball | Texas | United States |
| Orthopaedic Specialty Clinic | Spokane | Washington | United States |
| Latin Clinical Trial Center | San Juan | Puerto Rico |
| Reset | Jun 13, 2022 |
| Release | Sep 29, 2023 |
| Reset | Oct 24, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 18, 2021 | Nov 15, 2021 | |||
| May 16, 2022 | Jun 13, 2022 | |||
| Sep 29, 2023 | Oct 24, 2023 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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