NCT04084704已完成不适用
A Prospective Evaluation of the Cingal Injection for Hip Osteoarthritis (ECHO Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Patient reported hip pain as measured by Visual Analog Scale
研究概览
简要总结
Osteoarthritis (OA) of the hip is one of the ten most disabling diseases in the developed world. Because OA gradually worsens over time, the sooner treatment is started, the more likely its impact is lessened. Hip OA is characterized by joint pain, cartilage degeneration, and an increase in disability. Multiple treatments are used to manage the degenerating hip as well as the associated pain. These include physiotherapy and rehabilitation, bracing, other walking aids, oral medications, injections, and in severe cases, surgery. Prior research has shown that injection of hyaluronic acid (HA) and corticosteroids can slow down OA degradation. This study will look at the effects of injecting Cingal into the hip, which expands on its current approved use in the treatment of knee OA.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women ages 40 to 65 years
- •Hip OA (mild to moderate) diagnosed on x-ray and/or MRI (Tonnis grade 1 and 2)
- •Patient is using only nonsteroidal anti-inflammatory drugs (NSAIDs) or acetaminophen/ paracetamol (Tylenol) for pain relief during the month before receiving Cingal
- •Patient is willing to stop pain/anti-inflammatory medication at least two weeks prior to receiving Cingal through the end of the study (6 months)
- •Patient speaks, reads, and understands the language of the clinical site
- •Provision of informed consent
排除标准
- •Evidence of hip dysplasia (centre edge angle less than 20 degrees)
- •Presence of advanced hip OA (Tonnis Grade 3)
- •Previous trauma to the affected hip requiring medical or surgical treatment
- •Previous surgery on the affected hip or contralateral hip
- •Severe acetabular deformities (e.g. acetabular protrusion, coxa profunda, circumferential labral ossification)
- •Infections or skin diseases at target hip joint
- •Immunosuppressive medication use
- •Chronic pain syndromes
- •Significant medical co-morbidities (requiring daily assistance for activities of daily living)
- •History of paediatric hip disease (e.g. Legg-Calve-Perthes; slipped capital femoral epiphysis)
- •Previous cartilage repair procedure (microfracture, Osteochondral Autograft Transplantation System (OATS) or Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index hip)
- •Known hypersensitivity (allergy) to hyaluronan preparations
- •Known hypersensitivity (allergy) to triamcinolone hexacetonide preparations
- •Known sensitivity to any of the materials in Cingal
- •Patients with impaired cardio-renal function, endocrine, or other diseases or conditions that use of corticosteroid is warned
- •HA intra-articular injections into the index hip within the last 6 months before receiving Cingal
- •Corticosteroid therapy by systemic, intra-articular, or intramuscular route or oral corticosteroids within the last 6 months before receiving Cingal
- •Any injection received in the hip prior to receiving or received concurrently with Cingal
- •Uncontrolled diabetes
- •Subject is a woman who is pregnant or breastfeeding or a woman of child bearing potential who refuses to use effective contraception during the course of the study
- •Patient is incarcerated
- •Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- •Rheumatoid arthritis or gouty arthritis
- •Current diagnosis of osteomyelitis
- •Diagnosed musculoskeletal cancer or any diagnosed cancer, other than musculoskeletal if not on long term remission (e.g. at least 5 years or negative biopsy at last exam), except basal cell carcinoma
- •Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin or anti-platelet agents [e.g. ASA, Plavix]) or post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection)
- •Participation in concurrent trial that involves a medical intervention
- •Patient is currently receiving workman's compensation or disability, has been involved in an motor vehicle accident, or is in litigation for workman's compensation or disability claims
- •Likely problems, in the judgment of the treating physician, with maintaining follow up (e.g. patients with no fixed address, plans to move out of town). This may include patients with severe mental disorders and drug addictions without adequate support.
结局指标
主要结局
Patient reported hip pain as measured by Visual Analog Scale
时间窗: 6 months
The primary objective of this observational study is to determine, among individuals with hip OA ages 40-65 years, the effect of Cingal on patient-reported hip pain, as measured by a Visual Analogue Scale (VAS), at 6-months post-injection.
次要结局
- Physical activity levels as measured by a wrist-worn activity tracker(6 months)
- Health-related quality of life (HRQL) as measured by the Short Form-12 questionnaire (SF-12)(6 months)
- Complications, including infection and other adverse events at 6-months post-injection.(6 months)
- Range of motion(6 months)
- Hip Function, as measured by the Hip Disability and Osteoarthritis Outcome Score (HOOS)(6 months)
研究者
Olufemi Ayeni
Principal Investigator
McMaster University
研究点 (2)
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