Clinical Investigation of Sensovisc Sterile Sodium Hyaluronate Gel

NCT07232199 | Not Yet Recruiting DMC

• 1 other identifier: AnkaraCHBilkentHayriyesimsek03
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis

Keywords

viscosupplementation; hip osteoarthritis; hyaluronic acid; intraarticular injection; Sensovisc

Outcome Measures

Primary Outcomes (9)

• Visual Analogue Scale (VAS)

  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.

  Baseline

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

  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.

  6 weeks after the injection

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

  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.

  6 months after the injection

• WOMAC Osteoarthritis Index

  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.

  Baseline

• Change in WOMAC Osteoarthritis Score from baseline at 6 weeks

  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 weeks after the injection

• Change in WOMAC Osteoarthritis Score from baseline at 6 months

  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 months after the injection

• Harris Hip Score (HHS)

  It is a clinician-administered tool used to assess hip pain, function, deformity, and range of motion, with a total score ranging from 0 to 100 (higher scores indicate better function). Scores are categorized as excellent (90-100), good (80-89), fair (70-79), and poor (\<70). The HHS will be used to evaluate hip function before and after the intervention.

  Baseline

• Change in Harris Hip Score (HHS) from baseline at 6 weeks

  It is a clinician-administered tool used to assess hip pain, function, deformity, and range of motion, with a total score ranging from 0 to 100 (higher scores indicate better function). Scores are categorized as excellent (90-100), good (80-89), fair (70-79), and poor (\<70). The HHS will be used to evaluate hip function before and after the intervention.

  6 weeks after last injection

• Change in Harris Hip Score (HHS) from baseline at 6 weeks

  It is a clinician-administered tool used to assess hip pain, function, deformity, and range of motion, with a total score ranging from 0 to 100 (higher scores indicate better function). Scores are categorized as excellent (90-100), good (80-89), fair (70-79), and poor (\<70). The HHS will be used to evaluate hip function before and after the intervention.

  6 months after last injection

Study Arms (1)

Sensovisc®

EXPERIMENTAL

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

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

Interventions

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

Sensovisc®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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
• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead
• İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi: collaborator

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Hayriye Şimşek Özgüner

CONTACT

+90 5543814289; dr.hayriye.simsek@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11