This clinical investigation aims to investigate the safety and performance of Sensovisc. Sensovisc is used to reduce osteoarthritis (OA) related pain in the joints by supporting synovial fluid by intra-articular injection and allowing the synovial fluid to restore its viscoelastic properties. It increases the joint mobility by reducing or eliminating the pain. This Clinical Investigation was designed as a cross-sectional, interventional, and prospective study.
Osteoarthritis (OA) is the most prevalent chronic arthritis and a leading cause of pain and disability among adults. OA is a degenerative joint disease characterized by chronic inflammation, cartilage degradation and erosion of underlying bone in the affected joints, predominantly affects knees, significantly impacting patient mobility and quality of life. * Although there are currently no approved disease-modifying osteoarthritis drugs (DMOADs), nonpharmacologic interventions, such as physical therapy and weight management, and pharmaceutical approaches are available to reduce or revise joint damage and inflammation. * Among various therapeutic interventions, intra-articular hyaluronic acid (HA) injections have emerged as an alternative promising treatment. Emerging evidence suggests that HA may exert chondroprotective effects by enhancing synovial fluid viscosity, improving joint lubrication, and mitigating inflammatory processes, thereby potentially decelerating disease progression and preserving cartilage integrity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
75
Injectable Sterile Sodium Hyaluronate Gel
Visual Analogue Scale (VAS)
VAS at rest: Measures pain intensity while resting. Scale 0-10 cm (0 = no pain, 10 = worst imaginable pain). Higher scores = worse pain at rest. VAS at night: Measures pain intensity during the night, especially disturbing sleep. Scale 0-10 cm. Higher scores = worse nocturnal pain. VAS during activity: Measures pain intensity during movement or activity. Scale 0-10 cm. Higher scores = worse pain on activity.
Time frame: Baseline
WOMAC Osteoarthritis Index
The WOMAC Index is a self-administered questionnaire designed to evaluate symptoms and functional limitations in hip and knee osteoarthritis. It has 3 subscales: Pain (0-20) Stiffness (0-8) Physical function (0-68) The total score ranges from 0 to 96, with higher scores indicating worse pain, stiffness, and functional impairment.
Time frame: Baseline
Lequesne's Algofunctional Index for Knee
It measures three areas: Pain/discomfort (during activities and at rest), Maximum walking distance Daily living activities (like standing up, climbing stairs, squatting) The total score ranges from 0 to 24, with higher scores indicating greater disability: 1-4 = mild, 5-7 = moderate, 8-10 = severe, ≥14 = extremely severe.
Time frame: Baseline
Change in Visual Analogue Scale (VAS) score from baseline at 6 weeks
VAS at rest: Measures pain intensity while resting. Scale 0-10 cm (0 = no pain, 10 = worst imaginable pain). Higher scores = worse pain at rest. VAS at night: Measures pain intensity during the night, especially disturbing sleep. Scale 0-10 cm. Higher scores = worse nocturnal pain. VAS during activity: Measures pain intensity during movement or activity. Scale 0-10 cm. Higher scores = worse pain on activity.
Time frame: 6 weeks after last injection
Change in WOMAC Osteoarthritis Score from baseline at 6 weeks
The WOMAC Index is a self-administered questionnaire designed to evaluate symptoms and functional limitations in hip and knee osteoarthritis. It has 3 subscales: Pain (0-20) Stiffness (0-8) Physical function (0-68) The total score ranges from 0 to 96, with higher scores indicating worse pain, stiffness, and functional impairment.
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Time frame: 6 weeks after last injection
Change in Lequesne's Algofunctional Score from baseline at 6 weeks
It measures three areas: Pain/discomfort (during activities and at rest), Maximum walking distance Daily living activities (like standing up, climbing stairs, squatting) The total score ranges from 0 to 24, with higher scores indicating greater disability: 1-4 = mild, 5-7 = moderate, 8-10 = severe, ≥14 = extremely severe.
Time frame: 6 weeks after last injection
Change in Visual Analogue Scale (VAS) score from baseline at 6 months
VAS at rest: Measures pain intensity while resting. Scale 0-10 cm (0 = no pain, 10 = worst imaginable pain). Higher scores = worse pain at rest. VAS at night: Measures pain intensity during the night, especially disturbing sleep. Scale 0-10 cm. Higher scores = worse nocturnal pain. VAS during activity: Measures pain intensity during movement or activity. Scale 0-10 cm. Higher scores = worse pain on activity.
Time frame: 6 months after last injection
Change in WOMAC Osteoarthritis Score from baseline at 6 months
The WOMAC Index is a self-administered questionnaire designed to evaluate symptoms and functional limitations in hip and knee osteoarthritis. It has 3 subscales: Pain (0-20) Stiffness (0-8) Physical function (0-68) The total score ranges from 0 to 96, with higher scores indicating worse pain, stiffness, and functional impairment.
Time frame: 6 months after last injection
Change in Lequesne's Algofunctional Score from baseline at 6 months
It measures three areas: Pain/discomfort (during activities and at rest), Maximum walking distance Daily living activities (like standing up, climbing stairs, squatting) The total score ranges from 0 to 24, with higher scores indicating greater disability: 1-4 = mild, 5-7 = moderate, 8-10 = severe, ≥14 = extremely severe.
Time frame: 6 months after last injection
The usability of the devices
Device usability will be evaluated using a structured, multidimensional Device Usability Assessment Form, which includes five domains: Evaluation of the Product Instructions for Use Evaluation of the Surgical Technique Guide Evaluation of the Implant Card Evaluation of the Operation (Syringe Handling and Injection Procedure) Evaluation of Packaging The assessment form contains Likert-type items rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Strongly agree. A higher score reflects better usability, easier handling, clearer instructions, and improved user satisfaction.
Time frame: Baseline