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| Name | Class |
|---|---|
| İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi | UNKNOWN |
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This clinical investigation aims to investigate the safety and performance of Sensovisc.Sensovisc is used to reduce osteoarthritis 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.
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 OA 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensovisc® | Experimental | Other Names: Hyaluronic Acid Gel,Intra-articular injection,Sodium Hyaluronate Injectable Sterile Sodium Hyaluronate Gel |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SV-3-75: Sterile Sodium Hyaluronate Gel-3 mL Prefilled Syringe (2.5%) | Device | Sensovisc is used to reduce osteoarthritis 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. It will be injected in hip joint in this investigation. The injection will be administered under fluoroscopic and ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 6 weeks after the 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. | 6 months after the injection |
| 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. | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
Radiological Kellgren-Lawrence (K&L) stage I or IV
Other non-degenerative causes of hip pain
septic arthritis
Avascular necrosis,
Femoroacetabular impingement syndrome,
Trochanteric bursitis
Having a history of lower extremity fracture/surgery within the last 6 months
Pregnancy, breastfeeding, pregnancy plan
Morbidly obese patients (BMI>40),
Patients with unstable medical conditions (liver or kidney failure, lung/heart disease, tumor, HIV, etc.)
Known central nervous system and/or peripheral nervous system disease
When fluoroscopy guided injection is contraindicated:
Related to Treatment
Those who use blood thinners (warfarin compounds and heparin) or have bleeding problems
Contraindications for SENSOVISC: Hypersensitivity to product ingredients, systemic infection, presence of local infection on the buttocks, infection or skin disease at the injection site or joint area
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hayriye Şimşek Özgüner | Contact | +90 5543814289 | dr.hayriye.simsek@gmail.com |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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. |
| 6 weeks after the 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. | 6 months after the injection |
| Harris Hip Score (HHS) | It is a clinician-administered tool used to assess hip pain, function, deformity, and range of motion, with a total score ranging from 0 to 100 (higher scores indicate better function). Scores are categorized as excellent (90-100), good (80-89), fair (70-79), and poor (<70). The HHS will be used to evaluate hip function before and after the intervention. | Baseline |
| Change in Harris Hip Score (HHS) from baseline at 6 weeks | It is a clinician-administered tool used to assess hip pain, function, deformity, and range of motion, with a total score ranging from 0 to 100 (higher scores indicate better function). Scores are categorized as excellent (90-100), good (80-89), fair (70-79), and poor (<70). The HHS will be used to evaluate hip function before and after the intervention. | 6 weeks after last injection |
| Change in Harris Hip Score (HHS) from baseline at 6 weeks | It is a clinician-administered tool used to assess hip pain, function, deformity, and range of motion, with a total score ranging from 0 to 100 (higher scores indicate better function). Scores are categorized as excellent (90-100), good (80-89), fair (70-79), and poor (<70). The HHS will be used to evaluate hip function before and after the intervention. | 6 months after last injection |