An open-label, multicenter, prospective study to evaluate the safety and performance of intra-articular hyaluronic acid (BIOVISC ORTHO) in the management of wrist, elbow, shoulder and hip joint disorders
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) Pain rating
研究概览
简要总结
Title of StudyAnOpen-Label, Multicenter, Prospective Study to Evaluate the Safety and Performanceof Intra-Articular Hyaluronic Acid(BIOVISC ORTHO) in the Management of Wrist, Elbow, Shoulder and Hip JointDisorders
Study DesignProspective,Open-label, multi-center clinical study to evaluate safety and performance ofBIOVISC ORTHO in wrist, elbow, shoulderand hip joint.
Number of Subjects 96 Subjects
ObjectiveAssessthe safety and performance of BIOVISC ORTHO in patients with disorders inwrist, elbow, shoulder and hip joint.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild to moderate documented diagnosis of 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).
- •Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their 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.
- •greater then or equal to 50/100 VAS pain as a result of wrist, elbow, shoulder and hip joint disorders.
- •More then or equals to 3 months of pain after onset of symptoms that has failed conservative treatments (e.g., medications, physical therapy).
排除标准
- •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 joint, including arthroscopy.
- •Patients with neurological deficit, with primary inflammatory joint disease, intra-articular tumors.
- •Any severe systemic disease(s).
- •Patients who have received intra-articular hyaluronic acid within the previous 6 months and/or intra-articular steroids or articular lavage in the target joint 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
Visual Analog Scale (VAS) Pain rating
时间窗: Time Frame: At baseline (pre-intervention), 7days and 1 Month | At baseline (pre-intervention), 7D, and 1 Month | Through 6 Months
SF-36
时间窗: Time Frame: At baseline (pre-intervention), 7days and 1 Month | At baseline (pre-intervention), 7D, and 1 Month | Through 6 Months
Range of Motion (ROM) of Wrist/Elbow/Shoulder/Hip
时间窗: Time Frame: At baseline (pre-intervention), 7days and 1 Month | At baseline (pre-intervention), 7D, and 1 Month | Through 6 Months
All Adverse Events
时间窗: Time Frame: At baseline (pre-intervention), 7days and 1 Month | At baseline (pre-intervention), 7D, and 1 Month | Through 6 Months
次要结局
- American Shoulder and Elbow Surgeons (ASES) Standardized Shoulder Assessment form(At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months)
- Visual Analog Scale (VAS) Pain rating
- SF-12(At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months)
- Range of Motion (ROM) of Wrist/Elbow/Shoulder/Hip
- FIHOA(At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months)
- Change in Flexion-Abduction-External Rotation (FABER) Test(At baseline (pre-intervention), 7days, 1 Month, 3 Months, 6 Months)