Osteoarthritis, Knee
Conditions
Brief summary
The primary objective of this study is to assess the safety of a single injection of APS.
Detailed description
The primary objective of this study is to assess the safety of a single injection of APS in patients with painful unilateral knee osteoarthritis and who have not been able to get satisfactory pain relief with other treatments through one-month post treatment and monitor subjects for adverse events through 12 months.
Interventions
BIOLOGICALAPS
See above
Sponsors
Biomet Biologics, LLC
Zimmer Biomet
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male or female ≥40 and ≤75 years old at time of injection.. * A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 (within 6 months of screening). * Body mass index ≤40 kg/m2. * A Western Ontario and McMaster Universities osteoarthritis index using the Likert scale, Version 3. (WOMAC LK 3.1) pain subscale total score ≥ 10 and ≤ 19. * Has undergone at least two prior conservative OA therapies without satisfactory pain relief. * Patient has failed to get satisfactory pain relief from either HA or steroid injections or would be considered an appropriate patient to receive either HA or steroid injections
Exclusion criteria
* Presence of active infection or abnormal effusion in the knee immediately preceding treatment injection. * Presence of symptomatic OA in the non-study knee * Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases, or of metabolic origin; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, villonodular synovitis, and other non-OA joint disease. * Disease of spine, hip or other lower extremity joints of sufficient degree to affect assessment of the index knee * Untreated symptomatic injury of index knee (e.g., acute traumatic injury, anterior cruciate ligament injury, meniscus injury, cartilage lesion). * Knee radiographs showing bone-on-bone or other gross cartilage deficits. * Presence of surgical hardware or other foreign body in the index knee. * Intra-articular steroid injections in the index knee within 3 months of screening. * Intra-articular HA in the index knee within 6 months of screening. * Other intra-articular therapy in the index knee within 6 months prior to screening. * Systemic steroid use within 2 weeks of screening. * Planned/anticipated surgery of the index knee during the study period. * A history of local anesthetic allergy * Use of systemic immunosuppressants within six weeks of treatment. * Currently on anticoagulant therapy * Any documented clinically significant condition (e.g., diabetes, malignancy), finding, or psychiatric illness at screening which could compromise patient safety or interfere with the assessment of the safety and treatment effects of the study injection. * Skin breakdown at the index knee where the injection is planned to take place. * Pregnant or nursing mothers or women who are planning on getting pregnant during the time they will be participating in the study. * Known drug or alcohol dependence currently or within the last year. * Used any investigational drug or device within 30 days prior to screening. * Used any investigational biologic within 60 days prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 Year | Adverse Events and Serious Adverse Events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire | 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 consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain). The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness). The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation). |
| Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS) | 12 months | The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 no pain and 10 worst possible pain. Subjects rate their average pain over the last 24 hours. |
| Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) | 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 fewer 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). Traditionally in orthopedics, 100 indicates no problems and 0 indicates extreme problems. The normalized score is transformed to meet this standard. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| NStride APS Subjects will receive an intra-articular injection of APS. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Blood Draw for Device Processing | Insufficient blood could be drawn | 1 |
Baseline characteristics
| Characteristic | NStride APS |
|---|---|
| Age, Customized Mean Patient Age | 58.8 years STANDARD_DEVIATION 9.5 |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Adverse Events
Adverse Events and Serious Adverse Events
Time frame: 1 Year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NStride APS | Adverse Events | Adverse Events | 27 events |
| NStride APS | Adverse Events | Serious Adverse Events | 1 events |
Secondary
Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) is a validated measure of knee pain. The NRS is an 11 point Likert type scale anchored by 0 no pain and 10 worst possible pain. Subjects rate their average pain over the last 24 hours.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NStride APS | Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS) | NRS Pain - Baseline | 5.9 units on a scale | Standard Deviation 1.9 |
| NStride APS | Change From Baseline to 12 Months in Pain as Measured by the Numeric Rating Scale (NRS) | NRS Pain - 12 Months | 1.6 units on a scale | Standard Deviation 1.6 |
Secondary
Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS)
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 fewer 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). 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NStride APS | Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) | KOOS Pain - Baseline | 36.9 units on a scale | Standard Deviation 16.2 |
| NStride APS | Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) | KOOS Pain - 1 Week | 56.7 units on a scale | Standard Deviation 16.5 |
| NStride APS | Change From Baseline to 12 Months in Pain as Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) | KOOS Pain - 12 Months | 79.7 units on a scale | Standard Deviation 16.2 |
Secondary
Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire
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 consists of five questions scored from 0 to 4. The pain score has a range of 0 (no pain) to 20 (maximal pain). The WOMAC stiffness subscale consists of two questions scored from 0 to 4. The stiffness score has a range of 0 (no stiffness) to 8 (maximal stiffness). The WOMAC physical function subscale consists of seventeen questions scored from 0 to 4. The physical function score has a range of 0 (no functional limitation) to 68 (maximal functional limitation).
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| NStride APS | Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire | WOMAC Pain - Baseline | 12.2 units on a scale | Standard Deviation 1.7 |
| NStride APS | Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire | WOMAC Pain - 12 Months | 3.3 units on a scale | Standard Deviation 2.9 |
| NStride APS | Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire | WOMAC Stiffness - Baseline | 4.8 units on a scale | Standard Deviation 1.4 |
| NStride APS | Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire | WOMAC Stiffness - 12 Months | 1.6 units on a scale | Standard Deviation 1.7 |
| NStride APS | Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire | WOMAC Physical Function - Baseline | 38.6 units on a scale | Standard Deviation 9.4 |
| NStride APS | Change From Baseline to 12 Months in Pain, Stiffness, and Function in Daily Living Measured With WOMAC Questionnaire | WOMAC Physical Function - 12 Months | 12.1 units on a scale | Standard Deviation 9.8 |