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This is a two-phase multicenter, double-blind, randomized, prospective evaluation of intra-articular injection(s) comparing APS to intra-articular HA injection(s). The maximum study duration for each subject will be 50 months; 48 months from treatment to last follow-up, and two additional months if the maximum visit window is realized. A total of 246 patients will be enrolled. These patients will meet specific inclusion and exclusion criteria, but can be generally characterized as patients with painful unilateral knee OA who have been unable to achieve satisfactory pain relief with previous conservative OA treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nSTRIDE APS | Active Comparator | The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. |
|
| Synvisc-One | Active Comparator | Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nSTRIDE APS | Device | Intra-articular injection |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Months Post-injection in Mean WOMAC LK3.1 Pain Score in Both Arms of the Study (nSTRIDE APS and Synvisc One) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status. This section will only analyze the WOMAC pain score. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One) | In a Numerical Rating Scale (NRS) pain scale, patients are asked to circle (in an horizontal bar or line) the number between 0 and 10 that fits best to their average pain intensity. 0 = No pain at all; 5 = Moderate pain; 10 = Worst possible pain | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizaveta Kon | Humanitas Research Hospital IRCCS, Rozzano-Milan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Monica | Antwerp | Belgium | ||||
| The Parker Institute, Frederiksberg Hospital |
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Subjects giving written informed consent underwent screening assessments including demographics, medical history, physical examination, knee examination, a urine pregnancy test (if applicable) and the WOMAC LK 3.1. Upon confirmation of eligibility, subjects were scheduled for a treatment visit, and a baseline X-ray and MRI were performed.
The clinical investigation began on 25 July 2017 when the first subject received treatment. Subject recruitment was completed on 20 September 2018, when the last subject was randomized and received injection.
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| ID | Title | Description |
|---|---|---|
| FG000 | nSTRIDE APS | The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection |
| FG001 | Synvisc-One | Synvisc-One is intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | nSTRIDE APS | The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | mean age of all enrolled subjects at time of enrollment |
| 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 to 12 Months Post-injection in Mean WOMAC LK3.1 Pain Score in Both Arms of the Study (nSTRIDE APS and Synvisc One) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status. This section will only analyze the WOMAC pain score. | ITT population, with imputations for missing data | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
During the first phase of the study (up to 12 Months), all AEs were collected regardless of relationship to the device.
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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 | The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection site swelling | General disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Lead | Zimmer Biomet | +41791522905 | miguelcorreatapia@zimmerbiomet.com |
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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 | Mar 8, 2021 | Oct 5, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 24, 2019 | May 11, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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During the long-term follow-up phase (12 - 48 months), subjects may also elect to cross over to the other treatment arm and receive additional injections of the other treatment as frequently as needed, provided they did not experience any significant clinical concerns after previous treatment administrations and are benefiting from it, as determined by the investigator. Subjects may only cross over from their originally assigned treatment group to the other treatment group one time during the study.
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This is a double-blind study where subjects and evaluators are blinded to treatment up to 12-months. During the long-term follow-up phase (12 - 48 months), only subjects will be blinded to the study treatment resulting in single-blind design following 12-month follow-up time point.
| Synvisc-One | Device | Intra-articular injection |
|
|
| Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One) | The Outcome Measures in Rheumatology workgroup (OMERACT), together with the Osteoarthritis Research Society International (OARSI) developed the OMERACT-OARSI responder criteria. These criteria are used to determine if a patient with osteoarthritis (OA) 'responds' to therapy, meaning experiences a clinically relevant effect of therapy. It includes three symptomatic domains (pain, function, and patient's global assessment). To the question: High improvement in pain or in function (≥50%) and absolute change ≥20%, a positive answer is understood as "Response". A negative answer leads to an additional analysis, which seeks improvement in at least 2 of the 3 following:
| 12 months |
| Change From Baseline to 12 Months Post-injection in Mean WOMAC LK 3.1 Function Subscale in Both Arms of the Study (nSTRIDE APS and Synvisc One) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status. This section will analyze the WOMAC Function subscale. A subject is considered an MCID Function responder if they show an absolute improvement of >= 20 points in WOMAC Function from baseline to 12 Months. | 12 months |
| Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - VAS Score | The EurpoQol five-dimensional (EQ-5D) is a standardized instrument for measuring the health-related quality of life. Part of the Eq-5Q questionnaire consist of a visual analogue score (VAS), a vertical calibrated line, on which a patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). Respondents indicate where they perceive their present state of health to lie, relative to these anchors. | 12 months |
| Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - Health Status Score | The EurpoQol five-dimensional (EQ-5D), section Health Status, is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety depression. Each question has five levels of response (no problem, slight problem, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher score indicating higher health utility. | 12 months |
| Copenhagen |
| Denmark |
| Praxiskliniek für Unfallchirurgie und Orthopädie | Eisenach | Germany |
| KniePraxis | Straubing | Germany |
| Rizzoli Orthopedic Institute | Bologna | Italy |
| The Istituto Clinico Humanitas | Milan | Italy |
| Maastricht UMC+ | Maastricht | Netherlands |
| Oslo University Hospital - Olympiatoppen | Oslo | Norway |
| Hospital Clínic de Barcelona | Barcelona | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Madrid | Spain |
| Ospedale Regionale di Lugano | Lugano | Switzerland |
| Yildirim Beyazit University, School of Medicine | Ankara | Turkey (Türkiye) |
| Gloucestershire Hospitals NHS Foundation Trust | Cheltenham | United Kingdom |
| Royal Infirmary of Edinburgh - NHS Lothian | Edinburgh | United Kingdom |
| Withdrawal by Subject |
|
| exit for non-compliance |
|
| one subject was randomized but not treated |
|
| Other reasons |
|
| Synvisc-One |
Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| OG000 | nSTRIDE APS | The nSTRIDE APS Kit is designed to be used for the safe and rapid preparation of APS from a small sample of blood at the patient's point of care. The APS is to be injected intra-articularly for the treatment of knee osteoarthritis and associated symptoms. nSTRIDE APS: Intra-articular injection |
| OG001 | Synvisc-One | Synvisc-One is only intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection |
|
|
|
| Secondary | Change From Baseline to 12 Months Post-injection in Mean NRS Pain Scale in Both Arms of the Study (nSTRIDE APS and Synvisc One) | In a Numerical Rating Scale (NRS) pain scale, patients are asked to circle (in an horizontal bar or line) the number between 0 and 10 that fits best to their average pain intensity. 0 = No pain at all; 5 = Moderate pain; 10 = Worst possible pain | PP Population | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| Secondary | Number or Participants Achieving Clinical Success as Defined by OMERACT-OARSI Responder Criteria in Both Arms of the Study (nSTRIDE APS and Synvisc One) | The Outcome Measures in Rheumatology workgroup (OMERACT), together with the Osteoarthritis Research Society International (OARSI) developed the OMERACT-OARSI responder criteria. These criteria are used to determine if a patient with osteoarthritis (OA) 'responds' to therapy, meaning experiences a clinically relevant effect of therapy. It includes three symptomatic domains (pain, function, and patient's global assessment). To the question: High improvement in pain or in function (≥50%) and absolute change ≥20%, a positive answer is understood as "Response". A negative answer leads to an additional analysis, which seeks improvement in at least 2 of the 3 following:
| Posted | Count of Participants | Participants | 12 months |
|
|
|
|
| Secondary | Change From Baseline to 12 Months Post-injection in Mean WOMAC LK 3.1 Function Subscale in Both Arms of the Study (nSTRIDE APS and Synvisc One) | The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales: pain (5), stiffness (2), and physical function (17). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4). The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. The sum of the scores for all three subscales gives a total WOMAC score. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations. 0 represents the best health status and 96 the worst possible status. This section will analyze the WOMAC Function subscale. A subject is considered an MCID Function responder if they show an absolute improvement of >= 20 points in WOMAC Function from baseline to 12 Months. | MCID Function Responder analysis | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| Secondary | Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - VAS Score | The EurpoQol five-dimensional (EQ-5D) is a standardized instrument for measuring the health-related quality of life. Part of the Eq-5Q questionnaire consist of a visual analogue score (VAS), a vertical calibrated line, on which a patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health). Respondents indicate where they perceive their present state of health to lie, relative to these anchors. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| Secondary | Change From Baseline to 12 Months Post-injection in Mean EQ-5D in Both Arms of the Study (nSTRIDE APS and Synvisc One) - Health Status Score | The EurpoQol five-dimensional (EQ-5D), section Health Status, is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety depression. Each question has five levels of response (no problem, slight problem, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher score indicating higher health utility. | patients lost during follow-up | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
|
|
|
| 0 |
| 124 |
| 8 |
| 124 |
| 34 |
| 124 |
| EG001 | Synvisc-One | Synvisc-One is intended for intra-articular use by a physician to treat pain associated with osteoarthritis of the knee Synvisc-One: Intra-articular injection | 0 | 127 | 9 | 127 | 21 | 127 |
| Biliary colic | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Medial Meniscus Lesion+Cartilage Lesion at Medial Femoral Condyle Left Knee | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Uterine prolapse | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Wrist affected | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Biceps tendon rupture right arm | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment | After accident |
|
| Accute appendicitis | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Infection index knee | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Excessive swelling of Index Knee | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hypercalcemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Actinic and Seborhoeic Keratosis in scalp and right ear | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Hospital admission for gout in left (non index knee) | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Worsening of arthrosis left (non index) knee | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| gyneacological operation myom ovaries benigne | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
| Excessive pain of index knee | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ureteral colic (kidney stones) | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Vessel puncture site bruise | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA (10.0) | Systematic Assessment |
|
| Injection site pain | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Systematic Assessment |
|
| Venipuncture | Surgical and medical procedures | MedDRA (10.0) | Systematic Assessment |
|
Not provided
| 12 month follow-up |
|
|
| 12 month follow-up |
|
|