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This double-blind, multicenter, randomized, controlled trial (RCT) will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with osteoarthritis (OA) of the knee who have failed at least 1 conservative osteoarthritis (OA) therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).
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 who have failed at least 1 conservative OA therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| APS injection | Experimental | Autologous Protein Solution |
|
| Control | Placebo Comparator | Saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APS | Device | Intra-articular Injection |
| |
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain). | 6 months |
| Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain). | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 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:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DiMartino, MD | Bologna (Italy) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krems Hospital | Krems | Austria | ||||
| Monica Hospitals |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32870042 | Derived | Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G. Autologous Protein Solution Injections for the Treatment of Knee Osteoarthritis: 3-Year Results. Am J Sports Med. 2020 Sep;48(11):2703-2710. doi: 10.1177/0363546520944891. | |
| 29016185 | Derived | Kon E, Engebretsen L, Verdonk P, Nehrer S, Filardo G. Clinical Outcomes of Knee Osteoarthritis Treated With an Autologous Protein Solution Injection: A 1-Year Pilot Double-Blinded Randomized Controlled Trial. Am J Sports Med. 2018 Jan;46(1):171-180. doi: 10.1177/0363546517732734. Epub 2017 Oct 10. |
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Multicenter study, with 4 centers in Belgium, Italy, Austria and Norway. The first subject was enrolled on 8 May 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | APS Injection | Autologous Protein Solution APS: Intra-articular Injection |
| FG001 | Control | Saline: Intra-articular injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Patients who have OA in the knee who have failed at least 1 prior conservative OA therapy (e.g. physiotherapy, simple analgesics, intra-articular injection).
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| ID | Title | Description |
|---|---|---|
| BG000 | APS Injection | Autologous Protein Solution (APS): Intra-articular Injection |
| BG001 | Control | Saline: Intra-articular injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain). | The safety/ITT population analysis population was utilized for this analysis. | Posted | Mean | Standard Deviation | scores on a scale | 6 months |
|
Day 1, week 2, month 1, month 3, month 6 and month 12
Adverse Event reporting through 12-Month time point
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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 | APS Injection | Autologous Protein Solution: Intra-articular Injection | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Toothache | Gastrointestinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr. Cahit Akbas | Zimmer Biomet | +31622981737 | Cahit.Akbas@zimmerbiomet.com |
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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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| Device |
Intra-articular injection |
|
| 12 Months |
| Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC Stiffness subscale consisted of two questions scored from 0 to 4. The Stiffness has a range of 0(no stiffness) to 8 (maximal stiffness) | 12 months |
| Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC Physical Functioning subscale consisted of seventeen questions scored from 0 to 4. The Physical Functioning has a range of 0 (no functional limitation) to 68 (maximal functional limitation) | 12 months |
| Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | 12 months |
| Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | 12 months |
| Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | 12 months |
| Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | 12 months |
| Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | 12 months |
| Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Eight subscales of the Short Form-36 questionnaire are used to derive Physical Component and Mental Component measures | 12 Months |
| Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 12 Months |
| Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 12 Months |
| Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 12 Months |
| General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 12 Months |
| Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 12 Months |
| Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 12 Months |
| Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | 12 Months |
| Antwerp |
| Belgium |
| Rizzoli Orthopaedic Institute | Bologna | Italy |
| Oslo University | Oslo | Norway |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Autologous Protein Solution: Intra-articular Injection
| OG001 | Control | Saline: Intra-articular injection |
|
|
| Primary | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC pain subscale consisted of five questions scored from 0 to 4. The pain has a range of 0 (no pain) to 20 (maximal pain). | This data describes mITT/PP analysis set | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 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. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC Stiffness subscale consisted of two questions scored from 0 to 4. The Stiffness has a range of 0(no stiffness) to 8 (maximal stiffness) | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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|
| Secondary | Function on Daily Living Measured With WOMAC Subscale Questionnaire Physical Functioning at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The WOMAC LK 3.1 questionnaire is a validated tool commonly used for assessing knee pain, stiffness, and function. The WOMAC LK 3.1 questionnaire has 24 items that the patient addresses about the knee: 5 items on the pain subscale, 2 on the stiffness subscale, and 17 on the physical function subscale. Each item is answered on a 5-point Likert scale, with grading from 0 (none or never) to 4 (extreme or always). A higher score indicates worse pain, stiffness, or functional limitation. The WOMAC Physical Functioning subscale consisted of seventeen questions scored from 0 to 4. The Physical Functioning has a range of 0 (no functional limitation) to 68 (maximal functional limitation) | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| Secondary | Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| Secondary | Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Symptoms at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| Secondary | Function in Daily Living Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Function in Daily Living at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| Secondary | Sports and Recreational (Sport/Rec) Activities Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Sport/Rec at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 months |
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| Secondary | Quality of Life Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Subscale Quality of Life Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QOL) (4 questions). The previous week is used as the time period for answering the questions. A higher score on the KOOS questionnaire indicates no problems, and 0 indicates extreme problems. Each subscale score is calculated independently. The mean score of the individual items of each subscale is calculated and divided by 4 (the highest possible score for a single answer option). on). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | score on a scale | 12 months |
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| Secondary | Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. Eight subscales of the Short Form-36 questionnaire are used to derive Physical Component and Mental Component measures | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | score on a scale | 12 Months |
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| Secondary | Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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| Secondary | Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. | The 12 Month efficacy analyses were done on the mITT/PP analysis set. | Posted | Mean | Standard Deviation | scores on a scale | 12 Months |
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|
|
| 31 |
| 2 |
| 31 |
| 14 |
| 31 |
| EG001 | Control | Saline: Intra-articular injection | 0 | 15 | 1 | 15 | 6 | 15 |
| Nephrolithiasis | Renal and urinary disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Meniscus Injury | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| cholelithiasis | Hepatobiliary disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| hypersensitivity | Immune system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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| Vitamine D Deficiency | Metabolism and nutrition disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 16.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Alcoholic hangover | Psychiatric disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| pyrexia | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| influenza like ilness | General disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Gastrointestinal infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 16.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Joint crepitation | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Joint warmth | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Muscoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Rheumatic disorder | Musculoskeletal and connective tissue disorders | MedDRA version 16.0 | Non-systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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| Ligament Injury | Injury, poisoning and procedural complications | MedDRA version 16.0 | Non-systematic Assessment |
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