A Randomized Controlled Trial of Intra-Articular PRP, MFAT, and PRP-MFAT for Symptomatic Knee Osteoarthritis Treatment

The primary objective of this randomized control trial is to compare the efficacy of intra-articular infiltrations of **Platelet-Rich Plasma (PRP)**, Microfragmented Adipose Tissue (MFAT), and a combination of PRP-MFAT in the treatment of symptomatic **knee osteoarthritis**. This study aims to determine which treatment modality provides the most significant improvement in symptoms and joint function, thereby offering potential advancements in therapeutic strategies for managing this degenerative joint disease.

The clinical trial involves participants diagnosed with **knee osteoarthritis**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The general health status of participants is not specified, and the sponsor has not provided information regarding the total number of participants. The trial population was selected without targeting any vulnerable groups. There are no specific lifestyle considerations such as diet, physical activity, or habits mentioned. Key inclusion or exclusion criteria have not been detailed by the sponsor.

The clinical trial is designed to evaluate the efficacy of different intra-articular infiltrations in the treatment of **knee osteoarthritis**. This study is a **randomized, controlled trial** with a double-blind design to ensure unbiased results. The trial is set to commence on February 1, 2024, with an estimated completion date of February 1, 2028, indicating a total duration of four years. Participants will be randomly assigned to receive one of the following treatments: platelet-rich plasma (PRP), micro-fragmented adipose tissue (MFAT), or a combination of PRP and MFAT.

The sequence of study visits begins with an inclusion visit, where potential participants will undergo a screening process to determine eligibility based on predefined criteria. Following successful inclusion, participants will attend regular follow-up visits to monitor treatment effects and any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to evaluate the long-term outcomes of the treatments.

Participant involvement is expected to last throughout the trial duration unless specific conditions necessitate early termination. Such conditions may include the occurrence of serious adverse events, withdrawal of consent, or non-compliance with the study protocol. The trial aims to provide comprehensive data on the comparative effectiveness of the treatments, contributing valuable insights into the management of knee osteoarthritis.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of these details limits the ability to describe the treatment protocols accurately.

The clinical trial is set to commence recruitment on February 1, 2024, with an estimated completion date of February 1, 2028. The trial is categorized under Phase 5, indicating a post-marketing surveillance phase. Efficacy assessments will be conducted throughout the trial period, although specific parameters or endpoints for evaluating efficacy are not detailed in the provided data. The trial will likely involve systematic collection and analysis of data to assess the efficacy of the intervention, adhering to standard clinical trial protocols. The methods and schedule for measuring, collecting, and analyzing efficacy parameters are not specified in the available information. The trial will be conducted in accordance with regulatory standards to ensure the reliability and validity of the efficacy data collected.