Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine whether Gel-One demonstrates a superior effectiveness in osteoarthritis (OA) knee pain compared with phosphate buffered saline (PBS) injections.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gel-One | Active Comparator | 3 mL, a single intra-articular injection of Gel-One |
|
| Phosphate Buffered Saline (PBS) | Placebo Comparator | 3 mL, a single intra-articular injection of PBS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gel-One | Device |
| ||
| PBS |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model. | Baseline up to Week26 |
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 |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29644875 | Derived | Takamura J, Seo T, Strand V. A Single Intra-Articular Injection of Gel-200 for Treatment of Symptomatic Osteoarthritis of the Knee Is More Effective than Phosphate Buffered Saline at 6 Months: A Subgroup Analysis of a Multicenter, Randomized Controlled Trial. Cartilage. 2019 Oct;10(4):417-422. doi: 10.1177/1947603518768015. Epub 2018 Apr 12. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Gel-One | The participants received a single intra-articular injection of Gel-One. |
| FG001 | Placebo | The participants received a single intra-articular injection of Phosphate Buffered Saline (PBS). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Phase |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sheffield |
| Alabama |
| United States |
| Phoenix | Arizona | United States |
| Tucson | Arizona | United States |
| Anaheim | California | United States |
| Cerritos | California | United States |
| Costa Mesa | California | United States |
| Garden Grove | California | United States |
| North Hollywood | California | United States |
| San Diego | California | United States |
| Boulder | Colorado | United States |
| Englewood | Colorado | United States |
| Cos Cob | Connecticut | United States |
| Trumbull | Connecticut | United States |
| Oviedo | Florida | United States |
| Pinellas Park | Florida | United States |
| Plantation | Florida | United States |
| Sarasota | Florida | United States |
| Tamarac | Florida | United States |
| Tampa | Florida | United States |
| Marietta | Georgia | United States |
| Morton Grove | Illinois | United States |
| Newton | Kansas | United States |
| Wichita | Kansas | United States |
| Lake Charles | Louisiana | United States |
| Wheaton | Maryland | United States |
| St Louis | Missouri | United States |
| Trenton | New Jersey | United States |
| Hartsdale | New York | United States |
| New York | New York | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Altoona | Pennsylvania | United States |
| Duncansville | Pennsylvania | United States |
| Philadelphia | Pennsylvania | United States |
| State College | Pennsylvania | United States |
| Austin | Texas | United States |
| Bedford | Texas | United States |
| Charlottesville | Virginia | United States |
| Analyzed Participants | 5 subjects removed from ITT analyses because of no post treatment data. (Pre-defined) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Phase |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Gel-One | The participants received a single intra-articular injection of Gel-One. |
| BG001 | Placebo | The participants received a single intra-articular injection of PBS. |
| 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, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Body mass index | Mean | Standard Deviation | kilograms / meter square |
| |||||||||||||||
| Kellgren-Lawrence score | The Kellgren-Lawrence score is radiological classification of knee osteoarthritis. It progresses from grade 0 to grade IV and classified based on x-rays. | Number | participants |
| |||||||||||||||
| osteoarthritis knee disease duration | Mean | Standard Deviation | years |
| |||||||||||||||
| Etiology | Number | participants |
| ||||||||||||||||
| Study knee | Number | participants |
| ||||||||||||||||
| 50-foot walk test VAS pain score | Observed Visual Analogue Scale (VAS) pain score of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme target knee pain following 50-foot walk test. | Mean | Standard Deviation | mm |
| ||||||||||||||
| 50-foot walk test contralateral VAS pain score | Observed VAS pain score of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme contralateral knee pain following 50-foot walk test. | Mean | Standard Deviation | mm |
|
| 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 | Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test Through Week 26 | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline through week 26 was estimated using a longitudinal model. | Posted | Mean | 95% Confidence Interval | mm | Baseline up to Week26 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Post-Hoc | Change From Baseline in Visual Analogue Scores (VAS) Following 50-foot Walk Test at Week 26 | Observed VAS of 100 mm; 0 mm meaning no pain; 100 mm meaning extreme pain following 50-foot walk test. Change in score from baseline to week 26 was calculated as baseline minus week 26. | The post-hoc analysis plan pre-specified that only the change at week 26 in the Gel-One arm is intended to be analyzed. | Posted | Mean | 95% Confidence Interval | mm | Baseline and Week 26 |
|
|
25 months
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 | Gel-One | 3 mL, a single intra-articular injection of Gel-One. | 0 | 404 | 7 | 404 | 107 | 404 |
| EG001 | Placebo | 3 mL, a single intra-articular injection of PBS. | 0 | 410 | 6 | 410 | 113 | 410 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Systematic Assessment |
| ||
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Aortic valve incompetence | Cardiac disorders | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Deep vein thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Systematic Assessment |
| ||
| Ankle fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Joint effusion | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Development Dept. | Seikagaku Corporation | (81)3-5220-8948 | yuko.shibata@seikagaku.co.jp |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| Lost to Follow-up |
|
| Physician Decision |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Noncompliance with Study Protocol |
|
| Failure to Exam Primary Evaluation |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 2 |
|
| 3 |
|
| Post-traumatic |
|
| Left |
|
|
|