Clinical trial NCT02610192: nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis
Official title: A Prospective Study of a Single Intra-Articular Injection of Autologous Protein Solution in Females With Primary Patellofemoral Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patellofemoral Osteoarthritis
Keywords: Autologous Protein Solution
Patellofemoral Osteoarthritis
Female
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2015-11-20
Enrollment: 52
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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. 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).

Eligibility criteria: 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

Primary outcomes:
measure: Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
Secondary outcomes:
measure: Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: 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
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
measure: Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months
timeFrame: Baseline, 1, 3, 6 and 12 Months
Other outcomes:
Locations:
city: Deurne
country: Belgium
facility: AZ Monica
Study officials:
affiliation: AZ Monica, Deurne
name: Peter Verdonk, MD
role: PRINCIPAL_INVESTIGATOR
References: