Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07237711

Clinical Investigation of Sensovisc

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Osteo Arthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sensovisc®

Device

Injectable Sterile Sodium Hyaluronate Gel

Other names: Hyaluronic Acid Gel, Intra-articular injection, Sodium Hyaluronate

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 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.

  2. WOMAC Osteoarthritis Index

    Time frame: 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.

  3. Lequesne's Algofunctional Index for Knee

    Time frame: 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.

  4. Change in Visual Analogue Scale (VAS) score from baseline at 6 weeks

    Time frame: 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.

  5. Change in WOMAC Osteoarthritis Score from baseline at 6 weeks

    Time frame: 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.

  6. Change in Lequesne's Algofunctional Score from baseline at 6 weeks

    Time frame: 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.

  7. Change in Visual Analogue Scale (VAS) score from baseline at 6 months

    Time frame: 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.

  8. Change in WOMAC Osteoarthritis Score from baseline at 6 months

    Time frame: 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.

  9. Change in Lequesne's Algofunctional Score from baseline at 6 months

    Time frame: 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.

Secondary outcomes

  1. The usability of the devices

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hayriye Şimşek Özgüner

CONTACT

[email protected]

+90 312 552 60 00

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Collaborators

  • İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi

Registry information

Official study title

Clinical Investigation of Sensovisc Sterile Sodium Hyaluronate Gel in the Knee Joint

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 20, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.