CompletedNot Applicable

nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis

Belgium52 participantsStarted 2016-03

Plain-language 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.

Who can participate

Age range

40 Years – 65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT02610192

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-06

Results submitted2019-07-08

View on ClinicalTrials.gov More Patellofemoral Osteoarthritis trials