NCT00253799Unknown4 期
Prospective, Single Arm, Pilot Study Evaluating the Safety and Efficacy of Hyaluronan (Hylan GF-20) in Patients With Painful Shoulder Osteoarthritis
Northwestern Ophthalmic Institute S.C.0 个研究点目标入组 35 人开始时间: 2005年12月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 35
- 主要终点
- -Change from baseline to week 26 evaluation of patient's assessment of pain (VAS rest, motion, night)
研究概览
简要总结
The objective is to assess the safety and efficacy (over the course of 26 weeks) of 2 intra-articular (IA) Hylan GF-20 (Synvisc) injections in addition to customary care in patients with painful glenohumeral osteoarthritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Be will and able to provide written informed consent prior to any study-related procedures being performed and able to understand and comply with the requirements of this study.
- •Agree to receive fluoroscopically guided injections.
- •Be men or women aged 35 years or older.
- •If female and of childbearing age, must have a negative pregnancy test and have taken oral contraceptives for at least one month prior to treatment and continue for the duration of the study (up to and including the final study visit) or agree to use 2 forms of contraception; otherwise females must be surgically sterile or postmenopausal for at least one year.
- •Have painful, non-inflammatory unilateral osteoarthritis of the shoulder. OA in the contralateral shoulder is permissible provided that the OA symptoms are greater in the study joint. The presence of soft tissue pathology (e.g., rotator cuff tear) is permitted, and will be evaluated by an MRI (taken within 6 months of study entry).
- •Report an initial visual analogue pain score (VAS) of ≥ 30 and ≤
- •Have radiographic confirmation of osteoarthritis of the shoulder prior to baseline (modified Kellgren and Lawrence Numerical Grading System Grades II - IV) on radiographs performed within 12 weeks of screening
- •Have pain from shoulder OA requiring frequent (> 3 days/week) use of analgesics or NSAIDs for at least 8 weeks prior to screening.
排除标准
- •• Pregnant, lactating, or unwilling to use adequate contraception.
- •Prior viscosupplementation in target shoulder joint within 1 year of study entry.
- •Known sensitivity to avian protein or any components of hyaluronan based infection devices, steroids, lidocaine.
- •Known Sensitivity to contrast agent.
- •Used systemic steroids or have had an intra-articular steroid injection in the target shoulder within the last 3 months.
- •Rapidly progressive disease.
- •Acute disease or trauma leading to osteoarthritis of the joint within 2 years of study entry.
- •Presence of a primary inflammatory arthropathy (e.g., rheumatoid, psoriatic, or gouty arthritis).
- •Active skin or soft tissue infection in the area of the injection site.
- •Cervical spin disorders (e.g., radiculopathy) that have been symptomatic and required active treatment within the past 3 months.
- •Any active musculoskeletal condition that would impede measurement of the efficacy of the target shoulder joint (such as fibromyalgia).
- •Any major surgery, arthroplasty or arthroscopy in the target shoulder within 26 weeks of screening or planned surgery within the duration of the study.
- •Septic arthritis in any joints within 3 months prior to screening; any history of septic arthritis in the target shoulder.
- •Any significant chronic skin disorders that could interfere with the evaluation of the injection site.
- •Uncontrolled diabetes mellitus, diabetic neuropathy or infectious complications.
- •Active malignancy receiving treatment.
- •Taking warfarin or parental anticoagulant therapy.
- •Active asthma that may require periodic treatment with steroids during the study period.
- •Use of investigational drug, device, or biologic within 12 weeks of screening
- •Patients with ongoing litigation or workman's compensation claim.
结局指标
主要结局
-Change from baseline to week 26 evaluation of patient's assessment of pain (VAS rest, motion, night)
-Change from Baseline to follow-up in overall pain and function (WOMAC shoulder rating questionnaire)
次要结局
- -Absolute change in passive range of motion, in flexion, abduction, internal and external rotation
- -Requirements for rescue medication use for pain of the shoulder at each scheduled visit
研究者
相似试验
已完成
3 期
A Study to Evaluate the Clinical Performance and Safety of an Intra-articular Hyaluronic Acid in Knee OsteoarthritisKnee OsteoarthritisNCT03200288IBSA Institut Biochimique SA692
已完成
不适用
EVI-01-IT Safety StudyKnee OsteoarthritisNCT05422976Aptissen SA24
已完成
1 期
A Study of Single and Repeat Dose Administration of UBX0101 in Patients With Osteoarthritis of the KneeKnee OsteoarthritisNCT04229225Unity Biotechnology, Inc.35
招募中
1 期
A Study to Evaluate Mesenchymal Stem Cell Product StromaForte's Effect on Cardiovascular EventsCardiovascular DiseasesNCT06087848Cellcolabs Clinical LTD.100
已完成
3 期
Microfragmented Adipose Tissue Compared to Corticosteroid Injection for the Treatment of Knee OsteoarthritisOsteo Arthritis KneeKnee OsteoarthritisNCT05660772Lipogems International spa173