Clinical trial NCT02580643: Prospective Post-Market Data Collection on Patients With Knee OA and Treated With nSTRIDE APS
Official title: Prospective Post-Market Data Collection on Patients With Knee Osteoarthritis and Treated With nSTRIDE Autologous Protein Solution (REGP-22-00)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis, Knee
Keywords: Autologous Protein Solution
Osteoarthritis
Intra-articular Injection
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with bilateral or unilateral knee OA will be prospectively enrolled in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Knee pain and function
timeFrame: Through 12 months
Secondary outcomes:
measure: Characterize the time from the initial nSTRIDE injection to subsequent nSTRIDE injection(s) or other intrusive treatment.
timeFrame: Through 12 months
measure: Numeric Rating Scales (NRS)
timeFrame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
measure: European Quality of Life 5 Dimensions 3 Levels (EQ-5D-3L)
timeFrame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
measure: Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Evaluated at 2 and 4 weeks and 3, 6 and 12 months
measure: Procedural complications and adverse events
timeFrame: Through 12 months
Other outcomes:
Locations:
city: Northwood
country: United Kingdom
facility: BMI Bishops Wood Hospital
Study officials:
References: