Soft Tissue Adapted Hyaluronic Acid Functional Evaluation (SAFE): A Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- Visual Analog Scale (VAS) Pain
研究概览
简要总结
Soft Tissue Adapted Biocompatible Hyaluronic Acid, or STABHA™, has demonstrated varying degrees efficacy in patients treated for common musculoskeletal tendinopathies and ligament injuries, such as ankle sprains, lateral elbow tendinopathy, and rotator cuff tendinopathies. Factors associated with prognosis following treatment remain largely unknown. Identifying appropriate patient populations for use of STABHA™ is a necessary first step to facilitate the design of future clinical trials in the management of acute and chronic musculoskeletal soft-tissue injuries.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years of age or older.
- •Having a STABHA™ injection for the treatment of:
- •Acute first or second degree ankle sprain (e.g. occurred within the past 48 hours).
- •Lateral epicondylitis (tennis elbow).
- •Informed consent obtained.
排除标准
- •Medical contraindication to STABHA™.
- •Previous treatment with STABHA™.
- •Ankle or foot fracture.
- •Bilateral ankle sprain.
- •Previous ankle sprain in the past 12 months.
- •Prior surgical management of the ankle or elbow.
- •Current or anticipated incarceration.
- •Terminal illness with expected survival less than 90 days.
- •Currently enrolled in a study that does not permit co-enrollment.
- •Unable to obtain informed consent due to language barriers.
- •Unable to comply with the protocol.
- •Problems, in the judgment of study personnel, with maintaining follow-up with the patient.
- •Prior enrollment in the study.
- •Other reason to exclude the patient, as approved by the Sponsor.
结局指标
主要结局
Visual Analog Scale (VAS) Pain
时间窗: 12 months
A 100mm visual analog scale, with 0 representing no pain and 100 representing the worst pain imaginable. The patient will place an 'X' on the line which represents their current pain.
次要结局
- Adverse Events(12 months)
- EuroQol-5 Dimensions (EQ-5D)(12 months)
- 12-Item Short Form Survey Version 1 (SF-12V1)(12 months)
- Pain medication use(12 months)