Clinical Investigation of Sensovisc Sterile Sodium Hyaluronate Gel

Official title

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

Overview

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.

Interventions

• Device 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.

Primary outcome measures

• Visual Analogue Scale (VAS) [Time frame: Baseline]
• Change in Visual Analogue Scale (VAS) score from baseline at 6 weeks [Time frame: 6 weeks after the injection]
• Change in Visual Analogue Scale (VAS) score from baseline at 6 months [Time frame: 6 months after the injection]
• WOMAC Osteoarthritis Index [Time frame: Baseline]
• Change in WOMAC Osteoarthritis Score from baseline at 6 weeks [Time frame: 6 weeks after the injection]
• Change in WOMAC Osteoarthritis Score from baseline at 6 months [Time frame: 6 months after the injection]
• Harris Hip Score (HHS) [Time frame: Baseline]
• Change in Harris Hip Score (HHS) from baseline at 6 weeks [Time frame: 6 weeks after last injection]
• Change in Harris Hip Score (HHS) from baseline at 6 weeks [Time frame: 6 months after last injection]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07232199 · AnkaraCHBilkentHayriyesimsek03

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗