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

Zimmer Biomet78 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Osteoarthritis, Knee

Interventions

APSBIOLOGICAL

intra-articular injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

BMI Bishops Wood Hospital

Northwood, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.