Evaluation of Lipiodol® Embolization Safety in Refractory Symptomatic Digital Osteoarthritis: A Pilot Study on 15 Patients

The primary objective of this study is to evaluate the **safety** of Lipiodol® embolization in patients with symptomatic digital **osteoarthritis** that is refractory to conventional treatment. This condition is characterized by involvement of at least two proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints, with a Kellgren-Lawrence radiological stage of ≥ 2, and symptoms persisting for the last three months. Understanding the safety profile of this intervention is clinically relevant as it may offer a new therapeutic option for patients who do not respond to standard treatments, potentially improving their quality of life and managing symptoms more effectively.

The clinical trial involves participants diagnosed with **osteoarthritis** of the fingers, meeting the classification criteria of the American College of Rheumatology (ACR). The condition affects at least two proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints, with a Kellgren-Lawrence radiological stage of 2 or higher, and has been symptomatic in the past three months. The study population includes both male and female subjects, spanning age categories 3 and 4, which correspond to adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet or physical activity. The selection process for the trial population has not been disclosed.

The clinical trial is designed to evaluate the safety of **embolization** using Lipiodol® in patients with symptomatic digital osteoarthritis that is refractory to conventional treatment. This study is a Phase 2, pilot trial involving 15 participants. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial is four years, with recruitment anticipated to start on September 1, 2024, and the study expected to conclude by September 1, 2028.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on the American College of Rheumatology (ACR) criteria for digital osteoarthritis. This includes involvement of at least two proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) joints with a Kellgren-Lawrence radiological stage of 2 or higher, and symptoms present in the last three months. Following the screening, eligible participants will be randomized into the study groups. Subsequent follow-up visits will be scheduled to monitor the safety and efficacy of the intervention, with assessments conducted at regular intervals throughout the trial period. The end-of-study visit will occur at the conclusion of the trial to gather final data and ensure participant safety.

The expected length of participant involvement is approximately four years, aligning with the overall trial duration. Participants may be subject to early termination from the study if they experience adverse events that compromise their safety, fail to adhere to the study protocol, or withdraw consent. The trial is conducted in accordance with ethical standards and regulatory requirements to ensure the well-being of all participants.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, or frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 2 study, which typically focuses on assessing the efficacy of a treatment, as well as its side effects. The trial is scheduled to commence recruitment on September 1, 2024, with an estimated completion date of September 1, 2028. The specific parameters or endpoints used to evaluate efficacy, as well as the methods and schedule for measuring, collecting, and analyzing these parameters, are not detailed in the provided data. The trial will adhere to standard clinical trial protocols to ensure the reliability and validity of the efficacy assessments.