Prospective Single Centre Open Label Investigator Initiated Clinical Study to Evaluate the Efficacy and Safety of Cross-linked Intra-Articular Hyaluronic Acid (HA)(Biovisc Ortho Single) in Patients With Knee Osteoarthritis (OA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Change from Baseline to 3 Months and 6 Months in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
This prospective study was planned to carried out among the patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients clinic to evaluate the effectiveness and safety of viscosupplementation with intra-articular hyaluronic acid injection.
详细描述
The study was designed as prospective, single-center, single-arm, open-label, observational study. The patients with grade II and III (Kellgren Lawrence classification) osteoarthritis of the knee attending outpatients were planned to enroll the study. Patients between the age 18-80 years who did not achieve remission of pain despite receiving the first-line treatment for gonarthrosis including nonsteroidal anti-inflammatory drugs medication, activity modification and ice, were planned to included in the study. A single dose of HA will be injected into the target knee joint. Clinical evaluation will be done using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the short form-36 questionnaires (SF-36 v2) at baseline, 3 months and 6 months by a clinical secretariat.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients Age should not be less than 18 years.
- •Patients must be able to understand and follow the study procedures and must provide written informed consent.
- •Radiologically Grade II or III osteoarthritis of knee according to the Kellgren and Lawrence classification.
- •Mild to moderate documented diagnosis of knee osteoarthritis that fulfill the ACR (American College of Rheumatology) criteria.
- •Patients with consistent symptoms (joint pain, crepitus, swelling, effusion alone or combination of these symptoms) of knee osteoarthritis for at least 3 months prior to screening. If bilateral knee pain is present, the more painful knee will be selected.
- •Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their knee pain. However patients will be allowed to use only acetaminophen or aspirin as a rescue pain medication during the study period. The patients must abstain from medication use 24 hours prior to any study visit.
排除标准
- •Patients with secondary osteoarthritis of the knee according to ACR criteria.
- •Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception.
- •Patients unable to stay in the study for 6 months, non- cooperating, not able to understand
- •Patients having previously undergone surgery on target knee, including arthroscopy.
- •Patients with neurological deficit in the lower extremities, with primary inflammatory joint disease, intra-articular tumours.
- •Any severe systemic disease(s).
- •Any significant osteoarthritis symptoms in other joints apart from the target knee which may require pharmacological treatment during the study.
- •Patients who have received intra-articular hyaluronic acid within the previous 6 month and/or intra-articular steroids or articular lavage in the target knee within the previous 3 months prior to their inclusion in the study.
- •Administration of glucosamine sulphate, chondroitin sulphate and diacerein within the 3 months prior to their inclusion in the study.
- •History of allergy or hypersensitivity to hyaluronic acid.
- •Participation in any clinical study in the last 3 months and any surgery scheduled in the next 8 months that can affect directly the result of the present study.
结局指标
主要结局
Change from Baseline to 3 Months and 6 Months in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Baseline, 3 Months and 6 Months
WOMAC is health status measure questionnaire of twenty-four questions comprising 3 subscales (pain, stiffness and physical function). WOMAC was measured on a scale of 0-100 mm, where lower score represents lower pain and higher score represents higher pain.
Overview of Adverse Events (AE)
时间窗: Through study completion, an average of 6 Months
An AE could be any unfavorable and unintended symptom, sign, disease or condition, or test abnormality whether or not considered related to the investigational product. A serious adverse event (SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs (TEAE): AEs that developed/worsened during the 'on treatment period' (from first dose of study device until the end of study period). Category "AE" included participant with both serious and non-serious AE.
次要结局
- Change in quality of life measured by SF-36 questionnaire (Short Form Health Survey questionnaire)(Baseline,3 Months and 6 Months)
研究者
Esat UYGUR
Assoc. Prof. MD
Goztepe Training and Research Hospital