Clinical Investigation of Sensovisc

NCT07237711 | Not Yet Recruiting DMC

• 1 other identifier: AnkaraCHBilkentHayriyesimsek02
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteo Arthritis of the Knee

Keywords

viscosupplementation; knee osteoarthritis; hyaluronic acid; dosing; Sensovisc

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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.

  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 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.

  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.

  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.

  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.

  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.

  6 months after last injection

Secondary Outcomes (1)

• The usability of the devices

  Baseline

Study Arms (3)

SV-2-40 or SV-3-60

EXPERIMENTAL

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®

SV-2-32

EXPERIMENTAL

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®

SV-2-20

EXPERIMENTAL

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®

Interventions

Sensovisc® DEVICE

Injectable Sterile Sodium Hyaluronate Gel

Also known as: Hyaluronic Acid Gel, Intra-articular injection, Sodium Hyaluronate

SV-2-20; SV-2-32; SV-2-40 or SV-3-60

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi: collaborator

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Injections, Intra-Articular

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Hayriye Şimşek Özgüner

CONTACT

+90 312 552 60 00; dr.hayriye.simsek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Model Details: Patients are randomised to receive varying dosing regimens of Sensovisc

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 20, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11