An interventional study of Sensovisc® in Osteo Arthritis of the Knee, sponsored by Ankara City Hospital Bilkent. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment
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.
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's planned enrollment of 75 is close to the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with a Visual Analogue Scale (VAS) score of 80 mm or higher will receive a single injection of SV-3-60 (Sterile Sodium Hyaluronate Gel-3 mL Prefilled Syringe (2.0%)), whereas those with a score below 80 mm will receive a single injection of SV-2-40 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (2.0%) )
Device: Sensovisc®
For the patients who will be injected with SV-2-32 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (1.6%)), a second injection will be performed 1 week after the first injection.
Device: Sensovisc®
3 intra-articular injections of SV-2-20 (Sterile Sodium Hyaluronate Gel-2 mL Prefilled Syringe (1.0%)) administered 1 weeks apart. For the subject in the SV-2-20 group, a second and third injection will be performed one week and two weeks after the first injection.
Device: Sensovisc®
Injectable Sterile Sodium Hyaluronate Gel
Also known as: Hyaluronic Acid Gel, Intra-articular injection, Sodium Hyaluronate
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.
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
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This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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Ankara City Hospital Bilkent