Clinical Investigation of Sensovisc

Ankara City Hospital

Status: Not yet enrolling

Conditions: Osteo Arthritis of the Knee

Treatments: Device: Sensovisc®

Study type: Interventional

Funder types: Other

Identifiers

NCT07237711

AnkaraCHBilkentHayriyesimsek02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

SV-2-40 or SV-3-60

Experimental group

Description:

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%) )

Treatment:

Device: Sensovisc®

SV-2-32

Experimental group

Description:

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.

Treatment:

Device: Sensovisc®

SV-2-20

Experimental group

Description:

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.

Treatment:

Device: Sensovisc®