A Comparison of Orthovisc® to Corticosteroid Injection in Shoulder Osteoarthritis: Orthovisc Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 13
- 主要终点
- Visual Analog Scale (VAS) Pain Score (Per Protocol)
研究概览
简要总结
A comparison of Orthovisc to corticosteroid injections in the shoulder for pain due to osteoarthritis.
详细描述
This multicenter, prospective double-blinded, randomized trial will study two treatment groups. Subjects will be randomized to receive either Orthovisc or corticosteroids/anesthetic injection into the shoulder in a 2:1 schema. The trial will assess safety and efficacy of pain relief in the osteoarthritic shoulder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A candidate for unilateral treatment of osteoarthritis of the shoulder
- •Have failed conservative treatment
排除标准
- •Presence of full thickness Rotator Cuff tear and/or significantly compromised rotator cuff function
- •No active instability or acute dislocation episodes within the previous 12 months
- •Known allergy to hyaluronate preparations
- •Pregnant or breast feeding
- •Is receiving prescription pain medication for conditions unrelated to the index shoulder condition
研究组 & 干预措施
Control
Subjects randomized to the control arm injection of prescribed anesthetic and corticosteroid, shall receive an equivalent volume (8 mL's).
干预措施: Control (Drug)
Investigational
Subjects randomized to the active treatment in this study will receive a one-time dose of 8 mL's of Orthovisc derived from non-animal source bacterial fermentation, S. Equi.
干预措施: Orthovisc (Device)
结局指标
主要结局
Visual Analog Scale (VAS) Pain Score (Per Protocol)
时间窗: 6 Months
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
Visual Analog Scale (VAS) Pain Score (As Treated)
时间窗: 6 Months
Scores are measured on a 100 mm Visual Analog Scale (VAS). The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
次要结局
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (Per Protocol)(Baseline and 6 months)
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (As Treated)(Baseline and 12 weeks)
- Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (Per Protocol)(Baseline and 6 months)
- Percentage of Responders Using the Visual Analog Scale (VAS) Pain Score (As Treated)(Baseline and 6 months)
- Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (Per Protocol)(Baseline and 12 weeks)
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (Per Protocol)(Baseline and 6 months)
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 6 Months (As Treated)(Baseline and 6 months)
- Visual Analog Scale (VAS) Pain Score Change From Baseline and 12 Weeks (As Treated)(Baseline and 12 weeks)
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (Per Protocol)(Baseline and 12 weeks)
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (Per Protocol)(Baseline and 6 months)
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (As Treated)(Baseline and 12 weeks)
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (Per Protocol)(Baseline and 6 months)
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 12 Weeks (Per Protocol)(Baseline and 12 weeks)
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 12 Weeks (As Treated)(Baseline and 12 weeks)
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (Per Protocol)(Baseline and 12 weeks)
- American Shoulder and Elbow Surgeons Evaluation Form (ASES) Patient Score Change From Baseline and 6 Months (As Treated)(Baseline and 6 months)
- Shoulder Pain and Disability Index (SPADI) Total Disability Score Change From Baseline and 6 Months (As Treated)(Baseline and 6 months)
- 12-Item Short Form Survey (SF-12) Physical Score Change From Baseline and 12 Weeks (Per Protocol)(Baseline and 12 weeks)
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 6 Months (As Treated)(Baseline and 6 months)
- 12-Item Short Form Survey (SF-12) Mental Score Change From Baseline and 12 Weeks (As Treated)(Baseline and 12 weeks)