Clinical Investigation of Sensovisc Sterile Sodium Hyaluronate Gel

Ankara City Hospital

Status

Not yet enrolling

Conditions

Osteoarthritis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT07232199

AnkaraCHBilkentHayriyesimsek03

Details and patient eligibility

About

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.

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 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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