Osteo Arthritis of the Knee
Conditions
Keywords
OSTEOARTHRITIS OF THE KNEE , DIART ONE
Brief summary
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.
Detailed description
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.
Interventions
DRUGHyaluronic Acid (HA)
single injection of hyaluronic acid ( Diart) into the affected knee
Sponsors
Universiti Sains Malaysia
Hospital Universiti Sains Malaysia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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. Participants will receive a single intra-articular HA injection (Diart) and will be followed up at 0, 1, 3,6 and 12 months post-injection to assess outcomes.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
i. Adults aged 40-75 years with a clinical and radiographic diagnosis of knee OA (Kellgren-Lawrence grade II-III). ii. Persistent knee pain (≥4 on a 10-point Visual Analogue Scale \[VAS\]) for at least 3 months. iii. Failure to achieve adequate pain relief with conservative treatments (e.g., NSAIDs, physical therapy). iv. Willingness to provide informed consent and comply with study procedures.
Exclusion criteria
i. Severe OA (Kellgren-Lawrence grade IV). ii. History of knee surgery or HA injection within the past 6 months. iii. Inflammatory arthritis (e.g., rheumatoid arthritis, gout). iv. Contraindications to HA injections (e.g., infection, allergy to HA products). v. Significant comorbidities that may interfere with study participation (e.g., uncontrolled diabetes, morbid obesity, severe cardiovascular disease).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional assessment of patient with osteoarthritic knee included in this study | 1 YEAR | WOMAC osteoarthritis index is going to be used to assess the functionality of the patient with osteoarthritic knee, included in the study. Assessment is done 0, 1, 3, 6,12 months |
| Assessment of pain score in knee osteoarthritic patient | 1YEAR | The outcomes is measured using visual analogue score (VAS) for pain intensity assessment at 0, 1, 3, 6,12 months. |
Countries
Malaysia
Contacts
CONTACTSASSIDHAREN PONNALAGU, MEDICAL DEGREE
CONTACTAmran Prof. Dr A Shokri, master in orthopedics
PRINCIPAL_INVESTIGATORAMRAN AHMED SHOKRI, MASTER IN ORTHOPEDIC
Universiti Sains Malaysia
Outcome results
None listed