A Prospective Study of a Single Injection Cross-linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (CINGAL®) to Provide Symptomatic Relief of Osteoarthritis of Shoulder Joint
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 8
- 主要终点
- Numerical Rating Scale (NRS) Pain
研究概览
简要总结
This Trial will obtain clinical data to support an expanded indication for a single injection of Cingal used for the symptomatic relief of osteoarthritis in the shoulder joint.
详细描述
Single injection into the shoulder joint of a 4 ml unit dose of Cingal containing 88 mg (22 mg/ml) of cross-linked sodium hyaluronate and 18 mg (4.5 mg/ml) of triamcinolone hexacetonide (TH). Participants to be followed to 6 Months post-injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •History of hypersensitivity to any of the ingredients in the hyaluronan or corticosteroids
- •Infection or skin disease in the area of the injection site or index shoulder
- •NRS pain > 3 in the contralateral shoulder
- •Subject received an injection of Hyaluronic Acid (HA) and/or steroid in either joint within 6 months of signing the informed consent form (ICF). A subject will be excluded if they are planning to receive an HA or steroid injection (other than the study injection) in either joint during the course of this study.
- •Known inflammatory or autoimmune disorders (including rheumatoid arthritis, gout), or other pre-existing medical conditions that, in the opinion of the investigator, could impact treatment of the index shoulder or affect the ability of the subject to accurately complete the study questionnaires and comply with the study requirements.
- •Subject is taking medications at the time of signing the ICF which could interfere with the treatment procedure, healing and/or assessments. This includes but is not limited to oral or injectable anticoagulant treatments, anti-aggregant platelet treatment, chronic opioid analgesics. Low dose aspirin used for cardiovascular protection is allowed if a stable regimen is maintained for the duration of the study.
- •Subjects who had an oral, intramuscular, intravenous, rectal suppository or topical (excluded in index shoulder only) corticosteroid within 30 days of signing the ICF are excluded. Topical corticosteroid use at any site other than the index joint is allowed.
- •Significant trauma to the index shoulder within 26 weeks of screening.
- •Chronic use of narcotics or cannabis.
- •Baseline Exclusion Criteria
- •Subject has a decrease of ≥ 2 in the NRS pain from Screening to Baseline in the index shoulder.
- •Subject has a contraindication to continue with the study treatment injection based on the visual appearance of the synovial fluid aspirate.
研究组 & 干预措施
Cingal
Single injection of Cingal into the shoulder joint of subjects diagnosed with osteoarthritis of the shoulder.
干预措施: Cingal (Device)
结局指标
主要结局
Numerical Rating Scale (NRS) Pain
时间窗: 6 months
Reduction of Index Shoulder Numerical Rating Scale (NRS) Pain from baseline to 6 months post injection was obtained from participant responses. The NRS Pain Score is an 11-point Likert scale ranged from 0 = No Pain to 10 = Worst Pain level. A negative value for the change in NRS Pain Score indicates less pain post-treatment. A larger negative value indicates a higher level of improvement, and a better outcome.
次要结局
- Disabilities of the Arm, Shoulder and Hand (DASH) Score(6 Months)
- Patient Global Assessment (PGA) Score(6 Months)
- The Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. A Calculated Percentage (%) of Participants Responding to Treatment(6 Months)
- Usage of Rescue Medication (Acetaminophen/Paracetamol). Number of Participants NOT Using Rescue Medication.(6 Months)