nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

Zimmer Biomet52 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patellofemoral Osteoarthritis

Interventions

nSTRIDE Autologous Protein Solution (APS) KitDEVICE

Intra-articular injection of APS

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

AZ Monica

Deurne, Belgium

Outcomes

Primary Outcomes

Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months

The KOOS questionnaire is a commonly used instrument to assess the patient's opinion about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.