Health Condition 1: M171- Unilateral primary osteoarthritisof knee
Conditions
Interventions
Intervention1: Hydrogel OA 2%: One single injection of 2 mL Hydrogel OA 2% will be injected into the knee joint at Day 1.
Intervention2: Hydrogel OA 2%: One single injection of 1 mL Hydrogel OA 2% wil
Sponsors
Allegro NV/SA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults accepting to participate in the study and having signed the written informed consent form before any protocol-specific procedures and able to understand and follow the instructions as described in the protocol. 2. Unilateral symptomatic tibiofemoral KOA confirmed by a standing knee X-ray. In case of bilateral KOA on X-ray only one knee (index knee) presents symptomatic OA pain. 3. Age 35 more than equal to 75 years. 4. BMI 20 more than equal to 35. 5. KOOS Pain score 25 more than equal to 85. 6. Radiological K and L grade II and III from a standing index knee radiograph . 7. Fully ambulatory for functional assessments. 8. Willingness to refrain from taking any pain medication for 48 hours prior intraarticular injection. 9. Female participants must be on effective contraception (pill, patch, ring, diaphragm, implant or intrauterine device), if not surgically sterile (tubal ligation or hysterectomy) or postmenopausal for at least one year. If none of these criteria are met a pregnancy test must be performed at the treatment visit and the result should be negative.
Exclusion criteria
Exclusion criteria: 1. Bilateral tibiofemoral KOA where the non-index knee presents worse radiological grade of KOA than the index knee. 2. Radiological Kellgren and Lawrence grade 0, I, or IV of the index knee from a standing knee radiograph assessed during the screening visit, using the most recent x-ray taken either immediately or within the past 3 months. Significant clinically assessed varus or valgus deformation of the selected knee side of more than 10 degrees. 3. Extension deficit of the index knee higher than 5 degrees. 4. Bilateral symptomatic tibiofemoral KOA or ipsilateral symptomatic tibiofemoral knee and hip OA. 5. Clinical signs of significant effusion with noticeable swelling and/or inflammation related to severe pain during the treatment visit. 6. Active lymphatic or venous stasis or serious blood disorders (e.g., anemia), bleeding disorders (e.g., hemophilia), blood clots, or blood cancers (e.g., leukemia, lymphoma, and myeloma). 7. Active bacterial infection, resulting in hospitalization and/or requiring intravenous antibiotic treatment. 8. Synovial infection, skin infection or skin diseases in the area of the injection site. 9. History of autoimmune diseases that causes chronic joint pain and inflammation in the knee joint, including rheumatoid arthritis, psoriasis arthritis, juvenile idiopathic arthritis, systemic lupus erythematosus, gout, pseudogout, systemic sclerosis, Sj gren disease, adult-onset still disease. 10. Known or suspected generalized chronic pain disorder. 11. Severe alteration of mobility preventing any functional assessment. 12. Allergy or hypersensitivity to any of the product components of Hydrogel OA 2%. 13. Conditions (orthopedic, rheumatologic, musculoskeletal or inflammatory) causing symptomatic and/or radiating pain in the lower extremities that might interfere with the symptomatic OA knee pain, including hip OA assessed by physical examination by the physician. 14. Symptomatic patellofemoral KOA. 15. Oral corticosteroid therapy in the last 3 months before injection. 16. Severe acute illness within 14 days prior to investigational device administration. 17. Regular/chronic use of opioid drugs for pain control during the last 3 months before screening. 18. Use of opioid drugs within 7 days prior to the treatment visit. (However, opioid medications may be used for pain control during the study period.) 19. Pain Catastrophizing Scale score of 30 or higher than 30. 20. Any intra-articular injection (hyaluronan, hydrogel, soft implant, corticosteroid, platelet-rich plasma, local anesthetic etc.) arthroscopy, surgery in the index knee; or cell-based therapy or an invasive procedure on the index knee in the last 6 months before screening visit. 21. Anticipated need for any surgical or other invasive procedure throughout the course of the clinical investigation, including prosthesis in the index knee, any concurrent OA treatments including alternative treatments (e.g., acupuncture, ultrasound, magnetic resonance etc.). 22. Any investigator-assessed clinically significant condition that may represent a substantial risk to the patient or may have an impact on the study assessments. 23. Participation in another clinical trial in the last 3 months before injection. 24.Pregnancy and breastfeeding. 25.Legal incapacity or limited legal capacity to cons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The occurrence of any device or procedure related (serious) adverse event within 3 months after injection of the device.Timepoint: Day 1 to Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| The occurrence of any device or procedure related (serious) adverse event within 12 months after injection of the device.Timepoint: Day 1 to Day 365 | — |
Countries
India
Contacts
Public ContactMrs Aditi Vaidya
ProRelix Services LLP
Outcome results
None listed