nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02610192
• Date of registration: 10/11/2015
• Prospective Registration: Yes
• Primary sponsor: Zimmer Biomet
• Public title: nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis
• Scientific title: A Prospective Study of a Single Intra-Articular Injection of Autologous Protein Solution in Females With Primary Patellofemoral Osteoarthritis
• Date of first enrolment: March 2016
• Target sample size: 52
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02610192
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium

Contacts

• Name: Peter Verdonk, MD
• Affiliation: AZ Monica, Deurne

Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Patellofemoral Osteoarthritis

Intervention(s)

Device: nSTRIDE Autologous Protein Solution (APS) Kit

Primary Outcome(s)

Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months [Time Frame: Baseline, 1, 3, 6 and 12 Months]

Secondary Outcome(s)

Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months [Time Frame: 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 [Time Frame: 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 [Time Frame: Baseline, 1, 3, 6 and 12 Months]

Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months [Time Frame: 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 [Time Frame: Baseline, 1, 3, 6 and 12 Months]

Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months [Time Frame: Baseline, 1, 3, 6 and 12 Months]

Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months [Time Frame: Baseline, 1, 3, 6 and 12 Months]

Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months [Time Frame: 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 [Time Frame: Baseline, 1, 3, 6 and 12 Months]

Secondary ID(s)

APSS-55-00

BBIO.CR.APSPFO.001.15

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/12/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02610192