About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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)]

Trial design

Design model

Parallel

Treatments tested in this trial

Sensovisc®
Device
Injectable Sterile Sodium Hyaluronate Gel

Treatment groups

75 Participants

are divided into 3 treatment groups

Group A: SV-2-40 or SV-3-60Experimental treatment 1 intervention

Group B: SV-2-32Experimental treatment 1 intervention

Group C: SV-2-20Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame

Baseline

2

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.

Time frame

Baseline

3

Lequesne's Algofunctional Index for Knee

It measures three areas: Pain/discomfort (during activities and at rest), Maximum walking distance Daily living activities (like standing up, climbing stairs, squatting) The total score ranges from 0 to 24, with higher scores indicating greater disability: 1-4 = mild, 5-7 = moderate, 8-10 = severe, ≥14 = extremely severe.

Time frame

Baseline

4

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.

Time frame

6 weeks after last injection

Secondary outcomes

1

The usability of the devices

Device usability will be evaluated using a structured, multidimensional Device Usability Assessment Form, which includes five domains: Evaluation of the Product Instructions for Use Evaluation of the Surgical Technique Guide Evaluation of the Implant Card Evaluation of the Operation (Syringe Handling and Injection Procedure) Evaluation of Packaging The assessment form contains Likert-type items rated on a 5-point scale: 1 = Strongly disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Strongly agree. A higher score reflects better usability, easier handling, clearer instructions, and improved user satisfaction.

Time frame

Baseline

Locations

This trial has no locations.

Clinical Investigation of Sensovisc

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts