Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS

Study Overview
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Brief Summary
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This study will document treatment effects, changes in quality of life, procedure complications, adverse events, healthcare resource utilization, and further needed intervention(s) following treatment with nSTRIDE autologous protein solution. This study will also allow for the documentation of the same parameters following multiple injections of autologous protein solution to treat knee osteoarthritis.

Detailed Description
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Clinical trials have, in general, formally demonstrated the effectiveness and safety of various autologous therapies for the treatment of knee OA. Differences in the processing of autologous therapies can yield substantial differences in the resulting output. It appears that the safety of autologous therapies is roughly equivalent across different processing methods. However, making generalizations regarding the effectiveness across these autologous therapies is more complicated. Thus, each autologous therapy requires independent efficacy evaluation. nSTRIDE APS has been shown to decrease pain, increase function and have a favorable safety profile in a small pilot trial. However, demonstration of the treatment effects in a more heterogeneous population is lacking. Further, neither the effect time course nor the utility of multiple injections has been documented. This study will allow for low burden, efficient data collection in a larger heterogeneous population of persons suffering from knee OA. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following single or repeated injections.

Official Title
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Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00)

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Biological: APS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OA of one or both knees as diagnosed by the treating physician At least 18 years of age Willing and able to comply with the study procedures Signed informed consent form Exclusion Criteria: Any systemic inflammatory condition ( e.g., rheumatoid arthritis) Active malignancy at time of injection Pregnant at time of injection Lactating at the time of injection Knee joint infections or skin diseases or infections in the area of the injection site. Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment Participating in another device or drug study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| APS Injection<br>Autologous Protein Solution | Biological: APS<br>* intra-articular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee pain and function | Quantify and characterize the percentage of OMERACT-OARSI high improvement in pain responders at all post-injection time points. OMERACT-OARSI high improvement in pain responders are defined as subjects who show a 50% improvement in the KOOS pain sub-scale score and an absolute improvement of at least 20 points on the KOOS pain subscale score. | Through 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment. |  | Through 12 months | 
| Numeric Rating Scales (NRS) | Quantify the change in knee pain, stiffness and function | Evaluated at 2 and 4 weeks and 3, 6 and 12 months | 
| European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L) | Quantify the change in quality of life | Evaluated at 2 and 4 weeks and 3, 6 and 12 months | 
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Quantify changes in pain, symptoms, activities of daily life, engagement in sports and recreation and quality of living | Evaluated at 2 and 4 weeks and 3, 6 and 12 months | 
| Procedural complications and adverse events |  | Through 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autologous Protein Solution, Osteoarthritis, Intra-articular Injection