Clinical Investigation of Sensovisc Sterile Sodium Hyaluronate Gel

NCT ID: NCT07232199

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-25
• Study Completion Date: 2026-11-25

Brief Summary

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.

Detailed 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 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.

Conditions

Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sensovisc®

Other Names: Hyaluronic Acid Gel,Intra-articular injection,Sodium Hyaluronate Injectable Sterile Sodium Hyaluronate Gel

Group Type: EXPERIMENTAL

SV-3-75: Sterile Sodium Hyaluronate Gel-3 mL Prefilled Syringe (2.5%)

Intervention Type: 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.

Interventions

SV-3-75: Sterile Sodium Hyaluronate Gel-3 mL Prefilled Syringe (2.5%)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• >18 years old
• Patients who have unilateral and/or bilateral hip pain for more than 3 months and meet the diagnosis of coxarthrosis according to ACR criteria
• 40 mm above the pain level determined by the Visual Analogue Scale (VAS) during rest for at least 15 days in the month before starting the study (for paracetamol and oral NSAIDs, taking into account the half-life of the drug).
• Diagnosis of hip osteoarthritis with Stage II or III according to the Kellgren and Lawrence (KL) classification, as determined by x-rays taken in the last 12 months
• Ambulating with or without support
• Having the mental ability to express pain scores
• Signing the informed consent form indicating consent to participate in the study

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:

• pregnancy,
• contrast material allergy,
• local anesthetic allergy,
• Having conditions such as coagulopathy
• Related to Treatment

• Corticosteroid injection into the target joint within the last 1 month before the first injection
• Hyaluronan injection into the target joint within the last 6 months before the first injection
• Arthroscopy or surgery on the target joint within the last 6 months before the first injection
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi

UNKNOWN

Sponsor Role: collaborator

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Emre Adıgüzel

Prof. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hayriye Şimşek Özgüner

Role: CONTACT

dr.hayriye.simsek@gmail.com

+90 5543814289

Other Identifiers

AnkaraCHBilkentHayriyesimsek03

Identifier Type: -

Identifier Source: org_study_id