Clinical Investigation of Sensovisc
ConditionOsteo Arthritis of the Knee
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent
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
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
Treatments tested in this trial
- Sensovisc®
Treatment groups
75 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Ankara City Hospital Bilkent
Lead sponsor
İstem Medikal Tıbbi Cihaz ve Sanayi Ticaret Anonim Şirketi
Collaborator
Source ClinicalTrials.gov