An observational study in Osteoarthritis, Knee, sponsored by Zimmer Biomet. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-11.
Sponsored by Zimmer Biomet · Observational
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 78 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Zimmer Biomet is the lead sponsor of 271 studies on the registry; 28 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects with bilateral or unilateral knee OA will be prospectively enrolled in the study.
Exclusion Criteria:
Autologous Protein Solution
Biological: APS
intra-articular injection
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.
Time frame: Through 12 months
Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.
Time frame: Through 12 months
Numeric Rating Scales (NRS)
Quantify the change in knee pain, stiffness and function
Time frame: 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
Time frame: 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
Time frame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
Procedural complications and adverse events
Time frame: Through 12 months
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Zimmer Biomet