Osteoarthritis, Knee
Conditions
Keywords
Autologous Protein Solution, Osteoarthritis, Intra-articular Injection
Brief summary
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
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.
Interventions
BIOLOGICALAPS
intra-articular injection
Sponsors
Zimmer Biomet
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee pain and function | Through 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment. | Through 12 months | — |
| Numeric Rating Scales (NRS) | Evaluated at 2 and 4 weeks and 3, 6 and 12 months | Quantify the change in knee pain, stiffness and function |
| European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L) | Evaluated at 2 and 4 weeks and 3, 6 and 12 months | Quantify the change in quality of life |
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Evaluated at 2 and 4 weeks and 3, 6 and 12 months | Quantify changes in pain, symptoms, activities of daily life, engagement in sports and recreation and quality of living |
| Procedural complications and adverse events | Through 12 months | — |
Countries
United Kingdom
Outcome results
None listed