Osteo Arthritis of the Knee
Conditions
Keywords
viscosupplementation, knee osteoarthritis, hyaluronic acid, dosing, Sensovisc
Brief summary
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.
Detailed description
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.
Interventions
DEVICESensovisc®
Injectable Sterile Sodium Hyaluronate Gel
Sponsors
İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Ankara City Hospital Bilkent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Patients are randomised to receive varying dosing regimens of Sensovisc
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have unilateral and/or bilateral knee pain for more than 3 months and meet the diagnosis of osteoarthritis according to ACR criteria * Diagnosis of Stage II or III knee OA according to the Kellgren and Lawrence (K&L) classification, determined by x-rays taken in the last 12 months * 40 mm above the pain level determined by VAS during rest for at least 15 days in the month before starting the study (for paracetamol and oral nonsteroidal anti-inflammatory drugs (NSAIDs), taking into account the half-life of the drug) * Having a Body Mass Index (BMI) ≤ 40 kg/m², * Having the mental ability to express pain scores * Signing the informed consent form indicating consent to participate in the study
Exclusion criteria
* Radiological K&L stage I and IV * Acute inflammatory osteoarthritis attack (KOFUS ≥7) * Septic arthritis * Secondary OA \[Synovial chondromatosis or pigmented villonodular synovitis of the knee, Joint diseases (joint dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis), Inflammatory diseases (rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis)\] * Ipsilateral cruciate or collateral ligament injury in the last 3 months, * Corticosteroid injection into the target knee within the last 1 month before the first injection * Hyaluronat injection into the target knee within the last 6 months before the first injection * Arthroscopy or surgery on the target knee within the last 6 months before the first injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Lequesne's Algofunctional Score from baseline at 6 months | 6 months after last injection | 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. |
| Visual Analogue Scale (VAS) | Baseline | 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. |
| WOMAC Osteoarthritis Index | Baseline | 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. |
| Lequesne's Algofunctional Index for Knee | Baseline | 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. |
| Change in Visual Analogue Scale (VAS) score from baseline at 6 weeks | 6 weeks after last injection | 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. |
| Change in WOMAC Osteoarthritis Score from baseline at 6 weeks | 6 weeks after last injection | 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. |
| Change in Lequesne's Algofunctional Score from baseline at 6 weeks | 6 weeks after last injection | 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. |
| Change in Visual Analogue Scale (VAS) score from baseline at 6 months | 6 months after last injection | 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. |
| Change in WOMAC Osteoarthritis Score from baseline at 6 months | 6 months after last injection | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The usability of the devices | Baseline | 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. |
Contacts
Primary ContactHayriye Şimşek Özgüner
Outcome results
None listed