A Prospective Study of a Single Intra-Articular Injection of Autologous Protein Solution in Females With Primary Patellofemoral Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months
时间窗: Baseline, 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.
次要结局
- Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Function in Sport and Recreation (Sport/Rec) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Sport/Rec at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)
- Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months(Baseline, 1, 3, 6 and 12 Months)