Research Title: Long Term Functional Outcome of a Single Hyaluronic Acid Injection in Improving Symptoms and Function in Patients With Knee Osteoarthritis - A Single-Arm Open-Label Study (DIART ONE).

Overview

This study aims to evaluate the effectiveness of a single HA injection in improving pain, function, and quality of life in patients with knee OA over a 12-month period. By focusing on a single-arm open-label design, this study will provide practical insights into the real-world application of this treatment approach.

Single-arm, open-label studies play a crucial role in the clinical research ecosystem. These studies are often conducted to: 1. Assess the performance of a novel HA formulation (e.g., different molecular weights, cross-linking technologies). 2. Gather "real-world" evidence in broader, less restrictive patient populations. 3. Provide preliminary data to support the design of larger, more expensive RCTs. 4. Investigate outcomes in specific patient subpopulations (e.g., severe OA, different age groups). 1\. To compare mean differences VAS Score 0,1,3,6,12 months. 2. To study comparison WOMACS mean differences. 3. To document the safety and tolerability of a single HA injection in a real-world clinical setting.

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Central Contacts