Efficacy and Safety of Intraarticular Sodium Hyaluronate Single Injection in Patients With Osteoarthritis of the Knee

Launched by TEDEC-MEIJI FARMA, S.A. · Feb 22, 2019

Keywords

ClinConnect Summary

Prospective, multicentre and non-controlled study. Each patient will receive a single injection of SH 2% and will be followed for 1 year with follow up visits at 6 and 12 months At 6 months follow up visit patients will be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months From the pre-inclusion V0 up to the V1 (beginning of treatment), there will be a wash-out period of 2 weeks during which only paracetamol will be allowed for osteoarthritis (OA) pain relief (maximum dose allowed:3g/day).

Par...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient ≥ 45 years of age of either sex.
• • Primary knee OA of the medial or lateral femoro-tibial compartment documented according to ACR criteria with symptoms, at screening, from at least 3 months.
• • KL radiological grade 2-3.
• • Antero-posterior view X-Ray image of the target knee
• • Pain intensity at screening in the target knee ≥40 mm and \<80 mm measured by Visual Analogue Scale (VAS), and ≤ 20 mm in the contralateral knee.
• • Able to understand and willing to comply with study procedures.
• • Able to provide informed consent.
• Exclusion Criteria:
• • BMI ≥ 30 kg/m2.
• • Pregnant or lactating women. Women of child-bearing age not using effective contraception.
• • Severe inflammation of the target knee.
• • Previous surgery in the target knee, including arthroscopy.
• • Subjects with any musculoskeletal condition affecting the target knee that would impair the proper evaluation
• • Patients with joint inflammatory disease, microcrystalline arthropathies and significant osteoarthritis symptoms in other joints apart from the knee, and which require pharmacological treatment.
• • Underlying disease considered by the investigator that might interfere with the development and evaluation study.
• • Subjects with venous or lymphatic stasis in the relevant limb.
• • Previous administration of any of the following treatments: hyaluronic acid i.a. (last year); steroids i.a. or joint lavage (last 3 months), glucosamine sulfate, chondroitin sulfate or diacerein (last 3 months), NSAIDs (last 14 days), any investigational drug (last month) or its administration during this study.
• • Pain in other parts of the body greater than the knee pain that could interfere with the evaluation.
• • Any pathology that, under investigator judgement, interfere with the administration or assessment.
• • Patients with known hypersensitivity to SH or paracetamol.
• • Patients in waiting list for surgery.
• • Patients awaiting disablement assessment.
• • Previous participation in this protocol