Osteoarthritis, Knee
Conditions
Keywords
Autologous Protein Solution, APS, Osteoarthritis, Intra Articular Injection
Brief summary
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).
Detailed description
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).
Interventions
DEVICEAPS
Intra-articular Injection
DEVICESaline
Intra-articular injection
Sponsors
Zimmer Biomet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥40 years and ≤75 years. * Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions. * Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence scale * Body mass index (BMI) ≤ 40. * Failed at least 1 conservative OA therapy * Signed an independent ethics committee (IEC) approved informed consent form (ICF). Main
Exclusion criteria
* Intra-articular Hyaluronic (HA) injection within 6 months- On Day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling). * Presence of symptomatic OA in the non-study knee. * Diagnosed with rheumatoid arthritis (RA), Reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease \[IBD\], sarcoidosis, or amyloidosis) or of metabolic origin. * Diagnosis of isolated patella-femoral joint osteoarthritis. * Valgus/varus deformity judged by the investigator to be clinically significant. * Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the signal knee. Patients with TKR at the contra-lateral knee or THR in either hip may be enrolled provided sufficient pain relief after TKR or THR which does not require additional analgesic relief. * Untreated acute traumatic injury of the index knee. * Presence of a symptomatic meniscal tear in the index knee * Limited daily activity for reasons other than OA. * Presence of surgical hardware or other foreign body in the index knee.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | 6 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). |
| Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 | 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. |
| Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | 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 |
| Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 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. |
| Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | 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. |
| Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | 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. |
| General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | 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. |
| Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | 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. |
| Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | 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. |
| Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | 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. |
| Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | 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. |
| Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 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) |
Countries
Austria, Belgium, Italy, Norway
Participant flow
Recruitment details
Multicenter study, with 4 centers in Belgium, Italy, Austria and Norway. The first subject was enrolled on 8 May 2014.
Participants by arm
| Arm | Count |
|---|---|
| APS Injection Autologous Protein Solution (APS): Intra-articular Injection | 31 |
| Control Saline: Intra-articular injection | 15 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
Baseline characteristics
| Characteristic | APS Injection | Control | Total |
|---|---|---|---|
| Age, Continuous | 57.4 years | 54.1 years | 55.8 years |
| Region of Enrollment Belgium | 5 participants | 3 participants | 8 participants |
| Region of Enrollment Italy | 12 participants | 6 participants | 18 participants |
| Region of Enrollment Norway | 14 participants | 6 participants | 20 participants |
| Sex: Female, Male Female | 13 Participants | 6 Participants | 19 Participants |
| Sex: Female, Male Male | 18 Participants | 9 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 15 |
| other Total, other adverse events | 14 / 31 | 6 / 15 |
| serious Total, serious adverse events | 2 / 31 | 1 / 15 |
Outcome results
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).
Time frame: 6 months
Population: The safety/ITT population analysis population was utilized for this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | Week 2 | 8.6 scores on a scale | Standard Deviation 4 |
| APS Injection | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | 3 Months | 5.6 scores on a scale | Standard Deviation 3.9 |
| APS Injection | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | 1 Months | 7.0 scores on a scale | Standard Deviation 4.1 |
| APS Injection | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | 6 Months | 5.0 scores on a scale | Standard Deviation 3.8 |
| APS Injection | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | Day 1 | 11.5 scores on a scale | Standard Deviation 2.4 |
| Control | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | 6 Months | 5.6 scores on a scale | Standard Deviation 4.1 |
| Control | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | Day 1 | 11.8 scores on a scale | Standard Deviation 1.9 |
| Control | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | Week 2 | 8.7 scores on a scale | Standard Deviation 4.1 |
| Control | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | 1 Months | 8.4 scores on a scale | Standard Deviation 3.4 |
| Control | Change From Baseline to 6 Months in Pain Measured With WOMAC Questionnaire (Day 1, Week 2, Month 1, 3 and 6) | 3 Months | 5.7 scores on a scale | Standard Deviation 4.2 |
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).
Time frame: 12 Months
Population: This data describes mITT/PP analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | Day 1 | 11.5 scores on a scale | Standard Deviation 2.4 |
| APS Injection | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | Week 2 | 8.6 scores on a scale | Standard Deviation 4 |
| APS Injection | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 1 Month | 7.0 scores on a scale | Standard Deviation 4.1 |
| APS Injection | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 3 Months | 5.6 scores on a scale | Standard Deviation 3.9 |
| APS Injection | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 6 Months | 5.0 scores on a scale | Standard Deviation 3.8 |
| APS Injection | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 12 Months | 4.3 scores on a scale | Standard Deviation 4 |
| Control | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 6 Months | 5.6 scores on a scale | Standard Deviation 4.1 |
| Control | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | Day 1 | 11.8 scores on a scale | Standard Deviation 1.9 |
| Control | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 3 Months | 5.7 scores on a scale | Standard Deviation 4.2 |
| Control | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | Week 2 | 8.7 scores on a scale | Standard Deviation 4.1 |
| Control | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 12 Months | 6.3 scores on a scale | Standard Deviation 3.9 |
| Control | Pain Measured With WOMAC Questionnaire Subscale Pain at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months. | 1 Month | 8.4 scores on a scale | Standard Deviation 3.4 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 36.7 scores on a scale | Standard Deviation 7.6 |
| APS Injection | Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 44.0 scores on a scale | Standard Deviation 10.9 |
| APS Injection | Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 47.0 scores on a scale | Standard Deviation 9.3 |
| Control | Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 35.0 scores on a scale | Standard Deviation 7.9 |
| Control | Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 43.7 scores on a scale | Standard Deviation 7.2 |
| Control | Bodily Pain Measured With Short Form-36 (SF-36) Subscale Bodily Pain Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 39.2 scores on a scale | Standard Deviation 7 |
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.
Time frame: 12 months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | 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 | Day 1 | 48.6 scores on a scale | Standard Deviation 18.3 |
| APS Injection | 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 | Week 2 | 55.5 scores on a scale | Standard Deviation 21.8 |
| APS Injection | 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 | 1 Month | 63.4 scores on a scale | Standard Deviation 21.6 |
| APS Injection | 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 | 3 Months | 68.3 scores on a scale | Standard Deviation 21.3 |
| APS Injection | 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 | 6 Months | 72.8 scores on a scale | Standard Deviation 19.1 |
| APS Injection | 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 | Month 12 | 77.0 scores on a scale | Standard Deviation 20.3 |
| Control | 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 | 6 Months | 73.5 scores on a scale | Standard Deviation 18.7 |
| Control | 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 | Day 1 | 44.0 scores on a scale | Standard Deviation 13.7 |
| Control | 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 | 3 Months | 70.0 scores on a scale | Standard Deviation 19.8 |
| Control | 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 | Week 2 | 56.8 scores on a scale | Standard Deviation 22.2 |
| Control | 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 | Month 12 | 70.0 scores on a scale | Standard Deviation 18.1 |
| Control | 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 | 1 Month | 57.5 scores on a scale | Standard Deviation 15.9 |
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)
Time frame: 12 months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | 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 | Week 2 | 30.2 scores on a scale | Standard Deviation 14.8 |
| APS Injection | 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 | 3 Months | 21.5 scores on a scale | Standard Deviation 14.5 |
| APS Injection | 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 | 6 Months | 18.5 scores on a scale | Standard Deviation 13 |
| APS Injection | 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 | Day 1 | 34.9 scores on a scale | Standard Deviation 12.4 |
| APS Injection | 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 | Month 12 | 15.6 scores on a scale | Standard Deviation 13.8 |
| APS Injection | 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 | 1 Month | 24.9 scores on a scale | Standard Deviation 14.7 |
| Control | 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 | Month 12 | 20.4 scores on a scale | Standard Deviation 12.3 |
| Control | 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 | Day 1 | 38.1 scores on a scale | Standard Deviation 9.3 |
| Control | 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 | Week 2 | 29.4 scores on a scale | Standard Deviation 15.1 |
| Control | 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 | 1 Month | 28.9 scores on a scale | Standard Deviation 10.8 |
| Control | 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 | 6 Months | 18.0 scores on a scale | Standard Deviation 12.7 |
| Control | 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 | 3 Months | 20.4 scores on a scale | Standard Deviation 13.4 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 36.7 scores on a scale | Standard Deviation 7.6 |
| APS Injection | General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 44.0 scores on a scale | Standard Deviation 10.9 |
| APS Injection | General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 47.0 scores on a scale | Standard Deviation 9.3 |
| Control | General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 35.0 scores on a scale | Standard Deviation 7.9 |
| Control | General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 43.7 scores on a scale | Standard Deviation 7.2 |
| Control | General Health Measured With Short Form-36 (SF-36) Subscale General Health Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 39.2 scores on a scale | Standard Deviation 7 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 51.5 scores on a scale | Standard Deviation 8.5 |
| APS Injection | Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 54.1 scores on a scale | Standard Deviation 7.7 |
| APS Injection | Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 55.2 scores on a scale | Standard Deviation 7.4 |
| Control | Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 50.8 scores on a scale | Standard Deviation 8.9 |
| Control | Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 53.8 scores on a scale | Standard Deviation 6 |
| Control | Mental Health Measured With Short Form-36 (SF-36) Subscale Mental Health Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 53.0 scores on a scale | Standard Deviation 7.9 |
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.
Time frame: 12 months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | 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 | 3 Months | 64.1 scores on a scale | Standard Deviation 20.7 |
| APS Injection | 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 | Month 12 | 70.6 scores on a scale | Standard Deviation 21.5 |
| APS Injection | 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 | 1 Month | 58.2 scores on a scale | Standard Deviation 19.5 |
| APS Injection | 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 | Day 1 | 39.9 scores on a scale | Standard Deviation 13.1 |
| APS Injection | 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 | 6 Months | 66.6 scores on a scale | Standard Deviation 20.3 |
| APS Injection | 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 | Week 2 | 51.1 scores on a scale | Standard Deviation 19.7 |
| Control | 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 | 6 Months | 65.9 scores on a scale | Standard Deviation 19.2 |
| Control | 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 | 1 Month | 51.8 scores on a scale | Standard Deviation 16.3 |
| Control | 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 | 3 Months | 64.7 scores on a scale | Standard Deviation 20.8 |
| Control | 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 | Week 2 | 48.0 scores on a scale | Standard Deviation 16.6 |
| Control | 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 | Month 12 | 61.1 scores on a scale | Standard Deviation 18.5 |
| Control | 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 | Day 1 | 37.9 scores on a scale | Standard Deviation 10.1 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Week 2 | 4.7 scores on a scale | Standard Deviation 2.6 |
| APS Injection | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 3 Months | 3.3 scores on a scale | Standard Deviation 2 |
| APS Injection | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Day 1 | 5.5 scores on a scale | Standard Deviation 2.2 |
| APS Injection | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 6 Months | 3.1 scores on a scale | Standard Deviation 2.5 |
| APS Injection | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 1 Month | 4.0 scores on a scale | Standard Deviation 2.3 |
| APS Injection | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 12 Months | 2.6 scores on a scale | Standard Deviation 2.5 |
| Control | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 1 Month | 5.2 scores on a scale | Standard Deviation 2.1 |
| Control | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Day 1 | 6.5 scores on a scale | Standard Deviation 1.8 |
| Control | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Week 2 | 5.3 scores on a scale | Standard Deviation 2 |
| Control | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 12 Months | 4.8 scores on a scale | Standard Deviation 2.2 |
| Control | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 3 Months | 3.9 scores on a scale | Standard Deviation 2.1 |
| Control | Pain Measured With Visual Analogue Scale at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 6 Months | 4.1 scores on a scale | Standard Deviation 2.3 |
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
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 35.8 score on a scale | Standard Deviation 10 |
| APS Injection | Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | 6 Months | 43.3 score on a scale | Standard Deviation 9.2 |
| APS Injection | Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 43.5 score on a scale | Standard Deviation 10.2 |
| Control | Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 33.9 score on a scale | Standard Deviation 9.4 |
| Control | Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | 6 Months | 42.0 score on a scale | Standard Deviation 9.6 |
| Control | Physical Functioning Measured With Short Form-36 (SF-36) Subscale Physical Functioning Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 42.2 score on a scale | Standard Deviation 10.2 |
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.
Time frame: 12 months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | 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 | Day 1 | 26.5 score on a scale | Standard Deviation 13.8 |
| APS Injection | 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 | Week 2 | 29.0 score on a scale | Standard Deviation 22.4 |
| APS Injection | 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 | 1 Month | 30.7 score on a scale | Standard Deviation 27.6 |
| APS Injection | 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 | 3 Months | 37.7 score on a scale | Standard Deviation 27.1 |
| APS Injection | 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 | 6 Months | 39.1 score on a scale | Standard Deviation 25.3 |
| APS Injection | 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 | Month 12 | 51.3 score on a scale | Standard Deviation 25.3 |
| Control | 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 | 6 Months | 42.1 score on a scale | Standard Deviation 23.7 |
| Control | 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 | Day 1 | 22.3 score on a scale | Standard Deviation 8.7 |
| Control | 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 | 3 Months | 40.2 score on a scale | Standard Deviation 25.1 |
| Control | 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 | Week 2 | 23.2 score on a scale | Standard Deviation 15.3 |
| Control | 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 | Month 12 | 38.4 score on a scale | Standard Deviation 19.3 |
| Control | 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 | 1 Month | 26.8 score on a scale | Standard Deviation 18.8 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 44.0 scores on a scale | Standard Deviation 13.7 |
| APS Injection | Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 48.1 scores on a scale | Standard Deviation 10.7 |
| APS Injection | Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 49.6 scores on a scale | Standard Deviation 10.5 |
| Control | Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 39.5 scores on a scale | Standard Deviation 13.5 |
| Control | Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 47.5 scores on a scale | Standard Deviation 10.4 |
| Control | Role Emotional Measured With Short Form-36 (SF-36) Subscale Role Emotional Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 42.5 scores on a scale | Standard Deviation 9.8 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 38.5 scores on a scale | Standard Deviation 12 |
| APS Injection | Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 44.1 scores on a scale | Standard Deviation 12.4 |
| APS Injection | Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 46.0 scores on a scale | Standard Deviation 10.9 |
| Control | Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 38.8 scores on a scale | Standard Deviation 10.4 |
| Control | Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 45.7 scores on a scale | Standard Deviation 11.1 |
| Control | Role Physical Measured With Short Form-36 (SF-36) Subscale Role Physical Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 42.4 scores on a scale | Standard Deviation 9.3 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 43.7 scores on a scale | Standard Deviation 10.9 |
| APS Injection | Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 49.6 scores on a scale | Standard Deviation 9.7 |
| APS Injection | Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 51.5 scores on a scale | Standard Deviation 8.3 |
| Control | Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 44.5 scores on a scale | Standard Deviation 10.8 |
| Control | Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 51.4 scores on a scale | Standard Deviation 7.4 |
| Control | Social Functioning Measured With Short Form-36 (SF-36) Subscale Social Functioning Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 47.6 scores on a scale | Standard Deviation 9.7 |
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.
Time frame: 12 months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | 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 | Day 1 | 23.1 scores on a scale | Standard Deviation 25 |
| APS Injection | 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 | Week 2 | 29.0 scores on a scale | Standard Deviation 22.4 |
| APS Injection | 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 | 1 Month | 30.7 scores on a scale | Standard Deviation 27.6 |
| APS Injection | 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 | 3 Months | 37.7 scores on a scale | Standard Deviation 27.1 |
| APS Injection | 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 | 6 Months | 39.1 scores on a scale | Standard Deviation 25.3 |
| APS Injection | 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 | Month 12 | 47.1 scores on a scale | Standard Deviation 29.5 |
| Control | 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 | 6 Months | 42.1 scores on a scale | Standard Deviation 23.7 |
| Control | 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 | Day 1 | 14.3 scores on a scale | Standard Deviation 9.4 |
| Control | 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 | 3 Months | 40.2 scores on a scale | Standard Deviation 25.1 |
| Control | 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 | Week 2 | 23.2 scores on a scale | Standard Deviation 15.3 |
| Control | 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 | Month 12 | 37.1 scores on a scale | Standard Deviation 27.9 |
| Control | 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 | 1 Month | 26.6 scores on a scale | Standard Deviation 18.8 |
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)
Time frame: 12 months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Week 2 | 4.0 scores on a scale | Standard Deviation 2 |
| APS Injection | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 3 Months | 3.0 scores on a scale | Standard Deviation 1.6 |
| APS Injection | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Day 1 | 4.8 scores on a scale | Standard Deviation 1.7 |
| APS Injection | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 6 Months | 2.7 scores on a scale | Standard Deviation 2 |
| APS Injection | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 1 Month | 3.3 scores on a scale | Standard Deviation 1.8 |
| APS Injection | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Month 12 | 2.7 scores on a scale | Standard Deviation 1.7 |
| Control | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 1 Month | 3.9 scores on a scale | Standard Deviation 1.3 |
| Control | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Day 1 | 5.0 scores on a scale | Standard Deviation 1.2 |
| Control | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Week 2 | 3.6 scores on a scale | Standard Deviation 1.6 |
| Control | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | Month 12 | 3.0 scores on a scale | Standard Deviation 2 |
| Control | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 3 Months | 3.4 scores on a scale | Standard Deviation 1.5 |
| Control | Stiffness Measured With WOMAC Subscale Stiffness Questionnaire at Day 1, Week 2, 1 Month, 3 Months, 6 Months and 12 Months | 6 Months | 2.9 scores on a scale | Standard Deviation 1.6 |
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.
Time frame: 12 months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | 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 | Day 1 | 47.8 scores on a scale | Standard Deviation 19.3 |
| APS Injection | 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 | 2 Weeks | 55.4 scores on a scale | Standard Deviation 22 |
| APS Injection | 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 | 1 Month | 64.2 scores on a scale | Standard Deviation 20.4 |
| APS Injection | 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 | 3 Months | 65.3 scores on a scale | Standard Deviation 17.4 |
| APS Injection | 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 | 6 Months | 67.2 scores on a scale | Standard Deviation 20.3 |
| APS Injection | 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 | Month 12 | 68.4 scores on a scale | Standard Deviation 21.4 |
| Control | 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 | 6 Months | 63.3 scores on a scale | Standard Deviation 15.1 |
| Control | 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 | Day 1 | 46.4 scores on a scale | Standard Deviation 12.1 |
| Control | 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 | 3 Months | 62.5 scores on a scale | Standard Deviation 14.6 |
| Control | 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 | 2 Weeks | 54.9 scores on a scale | Standard Deviation 17.1 |
| Control | 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 | Month 12 | 58.2 scores on a scale | Standard Deviation 17.4 |
| Control | 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 | 1 Month | 56.1 scores on a scale | Standard Deviation 15.3 |
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.
Time frame: 12 Months
Population: The 12 Month efficacy analyses were done on the mITT/PP analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| APS Injection | Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 51.7 scores on a scale | Standard Deviation 9.9 |
| APS Injection | Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 54.0 scores on a scale | Standard Deviation 8.8 |
| APS Injection | Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 54.6 scores on a scale | Standard Deviation 9.9 |
| Control | Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | Day 1 | 50.6 scores on a scale | Standard Deviation 7.6 |
| Control | Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | Month 6 | 52.4 scores on a scale | Standard Deviation 6.5 |
| Control | Vitality Measured With Short Form-36 (SF-36) Subscale Vitality Questionnaire at Day 1, 6 Months and 12 Months | Month 12 | 53.1 scores on a scale | Standard Deviation 6.2 |