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A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee.
A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nSTRIDE APS | Experimental | Autologous Protein Solution prepared using the nSTRIDE APS Kit |
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| Saline | Other | Saline control |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nSTRIDE APS | Device | single intra-articular injection |
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| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months | The primary objective of this study was to determine whether nSTRIDE APS is superior to Saline with respect to the improvement in mean WOMAC Pain score (change from baseline to 12 Months post-injection raw score). The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain). | Baseline and 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months | The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick M Azar, M.D. | Campbell Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States | ||
| AVANT Research Associates, LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26915009 | Background | King W, van der Weegen W, Van Drumpt R, Soons H, Toler K, Woodell-May J. White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution. J Exp Orthop. 2016 Dec;3(1):9. doi: 10.1186/s40634-016-0043-7. Epub 2016 Feb 9. | |
| 27668131 |
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During the screening process, potential subjects provided informed consent and were then screened for eligibility. Screening consisted of meeting all inclusion and exclusion criteria, including a WOMAC LK 3.1 pain subscale score ≥ 9 and ≤ 19 and by providing objective physiological evidence of OA using the Kellgren-Lawrence scale (assessed from normal radiographs).
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| ID | Title | Description |
|---|---|---|
| FG000 | nSTRIDE APS | Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection |
| FG001 | Saline | Saline control Saline: single intra-articular injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 6, 2019 | Aug 27, 2023 |
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| Saline | Device | single intra-articular injection |
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| Baseline and 12 Months |
| Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders | The OMERACT-OARSI Responder Criteria were applied to both treatment groups, categorizing each patient into one of two categories: responder and non-responder. Responders were defined as subjects who achieved a high degree of improvement in pain or in function (improvement of ≥50% and absolute change ≥20), or a moderate degree of improvement in 2 of the 3 response domains (pain, function, global assessment). | 12 months |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months | The WOMAC stiffness subscale consisted of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness). | Baseline and 12 Months |
| EQ-5D Change From Baseline to 12 Months | The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-3L descriptive component assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over three levels of severity. The EQ visual analogue scale (EQ VAS) assesses the respondent's self-rated overall health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). | Baseline and 12 Months |
| Adverse Events | Subjects experiencing at least one AE | 12 months |
| Guntersville |
| Alabama |
| 35976 |
| United States |
| Tucson Orthopaedic Institute, PC | Tucson | Arizona | 85712 | United States |
| CORE Orthopaedic Medical Center | Encinitas | California | 92024 | United States |
| University of California at Los Angeles | Los Angeles | California | 90095 | United States |
| University of California, San Francisco | San Francisco | California | 94158 | United States |
| Andrews Research and Education Foundation (AREF) | Gulf Breeze | Florida | 32561 | United States |
| Florida Hospital Orthopaedic Institute and Fracture Care Center | Orlando | Florida | 32804 | United States |
| Comprehensive Clinical Trials, LLC | West Palm Beach | Florida | 33409 | United States |
| Orthoillinois, Ltd. | Rockford | Illinois | 61114 | United States |
| Orthopedic & Sports Medicine Center | Elkhart | Indiana | 46514 | United States |
| OrthoIndy | Greenwood | Indiana | 46143 | United States |
| Kansas University Medical Center Research Institute, Inc. | Kansas City | Kansas | 66160 | United States |
| Brigham and Women's Mass General Health Care Center | Foxborough | Massachusetts | 02035 | United States |
| Northwell Health - Great Neck | Great Neck | New York | 11021 | United States |
| Northwell Health - Lenox Hill | New York | New York | 10065 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati College of Medicine | Cincinnati | Ohio | 45229 | United States |
| Ohio State University | Columbus | Ohio | 43221 | United States |
| Joint Implant Surgeons, Inc | New Albany | Ohio | 43054 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| The Campbell Foundation | Germantown | Tennessee | 38138 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Texas Center for Joint Replacement | Plano | Texas | 75093 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| OrthoVirginia | Richmond | Virginia | 23294 | United States |
| van Drumpt RA, van der Weegen W, King W, Toler K, Macenski MM. Safety and Treatment Effectiveness of a Single Autologous Protein Solution Injection in Patients with Knee Osteoarthritis. Biores Open Access. 2016 Aug 1;5(1):261-8. doi: 10.1089/biores.2016.0014. eCollection 2016. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | nSTRIDE APS | Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection |
| BG001 | Saline | Saline control Saline: single intra-articular injection |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| WOMAC Pain | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain). | Mean | Standard Deviation | points |
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| 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 | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Likert (LK) 3.1 Pain Subscale Change From Baseline to 12 Months | The primary objective of this study was to determine whether nSTRIDE APS is superior to Saline with respect to the improvement in mean WOMAC Pain score (change from baseline to 12 Months post-injection raw score). The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain). | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 12 Months |
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| Secondary | Visual Analog Scale (VAS) Pain Change From Baseline to 12 Months | The Visual Analogue Scale is a common tool for measuring general pain. A 100 mm line is marked from 0 to 10 in 10 mm increments. Knee pain severity is indicated by drawing a vertical mark at the point on the line that best represents the severity of pain. No pain is indicated by the 0 at the far left, and the worst possible pain is indicated by the 100 at the far right. | Number of subjects with a completed VAS pain score at Baseline and at 12 Months | Posted | Mean | Standard Deviation | score on a scale | Baseline and 12 Months |
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| Secondary | Outcome Measures in Rheumatology - Osteoarthritis Research Society International (OMERACT-OARSI) Responders | The OMERACT-OARSI Responder Criteria were applied to both treatment groups, categorizing each patient into one of two categories: responder and non-responder. Responders were defined as subjects who achieved a high degree of improvement in pain or in function (improvement of ≥50% and absolute change ≥20), or a moderate degree of improvement in 2 of the 3 response domains (pain, function, global assessment). | Number of subjects with complete data at 12 Months to calculate responder status | Posted | Count of Participants | Participants | 12 months |
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| Secondary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) LK 3.1 Stiffness Subscale Change From Baseline to 12 Months | The WOMAC stiffness subscale consisted of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness). | Number of subjects with a completed WOMAC stiffness score at Baseline and at 12 Months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 12 Months |
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| Secondary | EQ-5D Change From Baseline to 12 Months | The EQ-5D is a validated instrument that assesses an individual's current health status and heath related quality of life. The EQ-5D-3L descriptive component assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression over three levels of severity. The EQ visual analogue scale (EQ VAS) assesses the respondent's self-rated overall health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state). | Number of subjects with a completed EQ-5D score at Baseline and at 12 Months | Posted | Mean | 95% Confidence Interval | score on a scale | Baseline and 12 Months |
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| Secondary | Adverse Events | Subjects experiencing at least one AE | Intent to Treat Population | Posted | Count of Participants | Participants | 12 months |
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| Post-Hoc | Post-Hoc Pain/Medication Usage Responder Analysis | This criteria is based on the usage of rescue medication and restricted medication/therapy usage and the WOMAC pain subscale percent change from baseline. A patient is considered a non-responder if one or more of the following are true:
| Per Protocol population at 12 Months | Posted | Count of Participants | Participants | Baseline and 1 Year |
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All AEs reported to or identified by investigative center personnel occurring during the study period, beginning on the day of procedure through completion of follow-up, an average of 12 months.
AEs had the onset and resolution date(s) listed (when known), and had their management and outcome documented (where feasible), and were assessed for severity, seriousness, relatedness, and whether they were anticipated. Narratives of SAEs were adjudicated by a Medical Monitor. An Independent Data Monitoring Committee (IDMC) also met periodically to review aggregate and individual subject data related to safety, data integrity and overall conduct of the trial.
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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 | nSTRIDE APS | Autologous Protein Solution prepared using the nSTRIDE APS Kit nSTRIDE APS: single intra-articular injection | 1 | 172 | 8 | 172 | 0 | 172 |
| EG001 | Saline | Saline control Saline: single intra-articular injection | 1 | 160 | 8 | 160 | 0 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Attack | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Cardiac Catherization, Stent Placement and Medication |
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| Death | Investigations | MedDRA (10.0) | Systematic Assessment | Not Noted |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| Excessive Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
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| GERD and Hiatal Hernia | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Nissen Fundoplication |
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| Right Knee Patella Pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | Contralateral Knee Patella Replacement |
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| Perforated Diverticulitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Bowel Rest and IV Antibiotics |
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| Acute Cholecystitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Laproscopic Cholecystectomy |
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| Lap Band Slippage and Diverticulitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Laparoscopic Revision of Gastric Band |
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| Confusion, Memory Loss | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Respiratory Syncytial Virus | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Oral and IV Corticosteroids |
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| Abnormal Cardiac Stress Test | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Heart Catheterization |
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| Kidney Stones | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment | Lithotripsy and Medication |
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| Thyroid Mass | Endocrine disorders | MedDRA (10.0) | Systematic Assessment | Partial Thyroidectomy |
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| Severe Dizziness | General disorders | MedDRA (10.0) | Systematic Assessment | Gait and Balance training |
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| Atrial Fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment | Cardio Conversion |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Woodell-May, Research Associate Director | Zimmer Biomet | 5742651885 | jennifer.woodell-may@zimmerbiomet.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 6, 2019 | Aug 27, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Male |
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| Asian or Pacific Islander |
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| Native American |
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| Not Specified |
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| Other |
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| White (Hispanic) |
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| White (Non-Hispanic) |
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