nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

Zimmer Biomet

Status

Completed

Conditions

Patellofemoral Osteoarthritis

Treatments

Device: nSTRIDE Autologous Protein Solution (APS) Kit

Study type

Interventional

Funder types

Industry

Identifiers

NCT02610192

BBIO.CR.APSPFO.001.15

APSS-55-00 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate clinical outcomes following a single injection of nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis. A secondary objective of this study is to document the duration of treatment effect following nSTRIDE injection.

Full 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. Thus, making generalizations regarding the effectiveness across these autologous therapies is more complicated. 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 pilot trial. Further, demonstration of the treatment effects in patellofemoral osteoarthritis, an important subset of knee osteoarthritis is lacking. This study will evaluate a population of female patients with patellofemoral osteoarthritis in which treatment with other modalities provides limited/short lived relief with the hope that APS treatment will provide and extend relief to these patients. The study will document the treatment effects and timeline of treatment effects for nSTRIDE APS following a single injection (per symptomatic knee).

Enrollment

52 patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must be female
Isolated patellofemoral osteoarthritis (PFOA) in one or both knees as diagnosed by the treating physician
Objective evidence of PFOA on one or both of a radiograph or MRI taken within 3 months of treatment
From 40-65 years of age, inclusive at time of injection
Symptoms return such that there is a need for further treatment within 3 months of a corticosteroid or hyaluronic acid injection
Willing and able to comply with the study procedures
Sign informed consent form

Exclusion criteria

Any systematic inflammatory condition (e.g. rheumatoid arthritis)
Active malignancy at time of injection
Pregnant at time of injection
Lactating at 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
Participation in another device, biologic or drug study