Knee osteoarthritis Musculoskeletal Diseases
Conditions
Interventions
The investigational medical device used in the investigation, Sinogel®, is a CE-marked medical device available in a 3.25 ml glass syringe containing 72.0 mg hyaluronic acid sodium salt and 48.0 mg of
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily given informed consent to investigation participation in writing, encompassing consent to data recording and verification procedures 2. Male and female patients aged = 45 and = 80 years 3. Patients affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for OA of the knee (CIP Appendix II), and meeting the following conditions: 3.1. Kellgren-Lawrence Grade 2 to 3 severity OA of the knee according to the Investigator’s judgment, with presence of osteophytes determined from X-rays of the knee obtained within 6 months from the screening visit; i.e. in the tibio-femoral compartment of the target knee with at least 1 osteophyte and measurable joint space, as diagnosed by standard X-rays (e.g. anterior-posterior view [weight bearing extension or semi-flexion] and lateral). In the case that a patient had not had a valid X-ray within 6 months prior to screening, the exam had to be performed during the screening period. 3.2. Patients suffering from OA symptoms of the target knee for at least 3 months prior to the screening visit Note: patients with bilateral OA of the knee were allowed as long as they could differentiate pain in the target knee, did not need to use analgesics for treatment of their contralateral knee, and did not expect to receive treatment of the contralateral knee during the investigation. In the case that both knees were eligible for the investigation based on pain intensity, the knee with the greater pain measured with a 100-mm visual analogue scale (VAS) was selected as the target knee. 4. Pain in the target knee of at least moderate intensity, i.e. a score =50 mm on a 0-100 mm VAS for pain 5. If a female of child-bearing potential, she had to have a negative urine pregnancy test at the screening visit and use a reliable form of contraception for more than 1 month prior to Screening and throughout the investigation. Note: to be considered females of non-child-bearing potential, females had to be surgically sterile or postmenopausal as documented in medical history for at least 1 year.
Exclusion criteria
Exclusion criteria: 1. Patients with symptoms that might be attributable to SARS-CoV-2 at the screening visit and in the 48 hours preceding the screening visit, or patients who had contact with subjects positive to SARS-CoV-2 in the 48 hours preceding the screening visit 2. Patients with osteoarthritis secondary to other articular diseases 3. Patients with rheumatoid arthritis or other systemic inflammatory processes 4. Patients with the presence of infections and/or skin diseases and/or skin wounds in the area to be treated 5. Patients having received: 5.1. Corticosteroids by systemic administration within 30 days prior to the screening visit (except inhaled corticosteroids) 5.2. Treatment with systemic short-acting (with a half-life less than 6 hours) non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen, ketoprofen) within 48 hours prior to the screening visit, or long-acting NSAIDs (e.g., piroxicam, naproxen), within 7 days prior to the screening visit. Note: The use of stable low daily doses of aspirin taken for non-analgesic reasons for at least 30 days prior to inclusion was permitted. 5.3. All other analgesic therapies within 7 days prior to the screening visit (12 hours for paracetamol) 5.4. Topical anti-inflammatory drugs and analgesics at the target knee within 7 days prior to the screening visit 5.5. Intra-articular treatments administration within 30 days prior to the screening visit and/or intra-articular corticosteroids administration within 60 days prior to the screening visit 5.6. Chondroitinsulphate, glucosamine sulphate, diacereine, bisphosphonates or matrix metalloproteinase (MMP) inhibitors administration within 30 days prior to the screening visit 5.7. Viscosupplementation of the target knee within 6 months prior to the screening visit 5.8. Oral anticoagulants within 30 days prior to the screening visit 5.9. Alternative medicine (e.g. acupuncture) for treatment of the affected area within 60 days prior to the screening/baseline visit 5.10. Treatment with any other investigational product within 3 months prior to the screening visit 6. Patients having received treatments or physical therapies (i.e. laser therapy, ultrasound therapy, antalgic electrotherapy, tecar therapy, physiotherapy), which could interfere with either the local injection of the investigational device or the evaluations of investigation results within 7 days prior to the screening visit 7. Patients receiving treatment with 3-hydroxy-3-methyl glutaryl coenzyme A reductase inhibitors (statins) 8. Patients having had any previous surgery in the target knee within 6 months prior to the screening visit, or any planned surgery throughout the duration of the investigation 9. Patients having had diagnostic or surgical knee arthroscopy, or knee lavage in the target knee in the 6 months prior to the screening visit 10. Known or suspected hypersensitivity to hyaluronic acid or any other component of the investigational device and/or paracetamol 11. Patients with body mass index (BMI) > 40 kg/m2 12. Patients who were candidates for knee replacement within the next 6 months 13. Patients with a large intra-articular effusion of the target knee 14. Patients with significant pain outside the target knee, including significant hip or back pain 15. Patients with clinically significant valgus/varus deformities (>20°) or ligamentous laxity as assessed by the Investigator 16. Patients with any musculoskeletal condition affecting the target knee that would impair assessment of t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and nature of treatment-emergent adverse events (TEAEs) measured using data collected from Case Report Forms (CRFs) at one timepoint 2. Incidence and nature of the Serious Adverse Device Effects (SADEs) measured using data collected from CRFs at one timepoint 3. Incidence and nature of the Adverse Device Effects (ADEs) measured using data collected from CRFs at one timepoint 4. Incidence and nature of investigational medical Device Deficiencies (DDs) measured using data collected from CRFs at one timepoint 5. Changes from baseline to any post-baseline on-site visit in vital signs (heart rate and blood pressure) measured using data collected from CRFs at one timepoint 6. Local tolerability parameters (pain, erythema, swelling and hardening in the site of injection) measured using 4/7-point scales at Day 0, Day 7 ± 2 days from the injection, Day 14 ± 2 days from the injection and Day 28 ± 2 days from the injection | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain measured using a Visual Analogue Scale (VAS) for pain (0-100 mm); changes from baseline to Day 7 ± 2 days from the injection, Day 14 ± 2 days from the injection, Day 28 ± 2 days from the injection and 6 months ± 1 week from the injection 2. Use of rescue medication (paracetamol): number and proportions of users, and average tablet count per day, will be measured using data collected through a self-report diary provided to each patient and used throughout the post-baseline period | — |
Countries
Italy
Contacts
Public ContactTania Patruno
Outcome results
None listed