N/A
N=50
nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis
Patellofemoral Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT02610192 ↗Enrolled (actual)
50
Serious AEs
6.0%
Results posted
Dec 2019
Primary outcome: Primary: Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months — 40.3; 53.5; 52.5; 54.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- nSTRIDE Autologous Protein Solution (APS) Kit (Device)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Zimmer Biomet
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months |
40.3; 53.5; 52.5; 54.9; 57.3 | — |
| SECONDARY Symptoms Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale Symptoms at 1, 3, 6 and 12 Months |
46.9; 59.2; 61.4; 61.5; 62.5 | — |
| SECONDARY Function in Daily Living (ADL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale ADL at 1, 3, 6 and 12 Months |
45.9; 58.8; 57.9; 59.7; 62.0 | — |
| SECONDARY 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 |
11.2; 23.0; 20.8; 22.4; 22.9 | — |
| SECONDARY Quality of Life (QoL) Measured With Knee Injury and Osteoarthritis Outcome Score (KOOS) Questionnaire Subscale QoL at 1, 3, 6 and 12 Months |
29.7; 37.5; 37.0; 36.3; 38.2 | — |
| SECONDARY Pain Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Pain at 1, 3, 6 and 12 Months |
6.7; 4.9; 5.0; 4.7; 4.5 | — |
| SECONDARY Stifness Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Stiffness at 1, 3, 6 and 12 Months |
6.0; 4.3; 4.5; 4.1; 4.0 | — |
| SECONDARY Function Measured With Numeric Rating Scales (NRS) Questionnaire Subscale Function at 1, 3, 6 and 12 Months |
6.6; 4.9; 4.7; 4.7; 4.4 | — |
| SECONDARY Patellofemoral Pain and Function Measured With Kujala Anterior Knee Pain Assessment Questionnaire (KAKPAQ) Questionnaire at 1, 3, 6 and 12 Months |
48.4; 55.4; 54.8; 57.0; 56.3 | — |
| SECONDARY Activity Measured With UCLA Activity Score Questionnaire at 1, 3, 6 and 12 Months |
5.0; 5.3; 5.5; 5.2; 5.6 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02610192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.