Randomized Control Study Comparing Efficacy of a Dehydrated Cell and Protein Concentrate (dCPC) ("Ascent") Versus Corticosteroid
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- StimLabs
- 入组人数
- 51
- 试验地点
- 8
- 主要终点
- Measuring changes in quality of life due to treatment, as assessed by patient reported survey.
研究概览
简要总结
To compare the efficacy of Ascent injection versus corticosteroid injection in treating knee osteoarthritis.
详细描述
To compare the functional outcomes in patients undergoing treatment of knee osteoarthritis using cortisone steroid injections (CSI) or a dehydrated cell and protein concentrate (dCPC) product, Ascent
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than 20 years but less than 75 years old
- •Both male and female (non-pregnant)
- •Valid knee radiograph within 3 months of beginning treatment;
- •Diagnosis of OA of the knee
- •OA pain in the knee despite conservative measures
- •Average daily VAS >= 3
- •Off any NSAIDs for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection
- •Kellgren-Lawrence system of Grade II, III, or IV
排除标准
- •Kellgren-Lawrence Grade I
- •Tense effusion of the knee
- •Significant valgus/varus deformities
- •Viscosupplementation within 6 months
- •Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening
- •Chronic opioid usage
- •History of Leukemia or Lymphoma
- •History of any autoimmune disorders and disease
- •Immunosuppressive medications
- •Active, suspected, or prior infection to the joint
- •Vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...)
- •NSAIDs used within 1 week of the procedure
- •History of bleeding disorders or inflammatory joint disease
- •Patients who plan on becoming pregnant during study period
结局指标
主要结局
Measuring changes in quality of life due to treatment, as assessed by patient reported survey.
时间窗: 12 months
The Quality of Life Survey is a patient-reported outcome measure divided into two parts. The first part of the Quality of Life questionnaire/survey will include 4 questions in which patients will be asked to evaluate their individual levels of knee problems (knee difficulty, knee confidence, and lifestyle modifications). Answers will be reported on a 5 point likert scale, in which higher scores indicate more severity, and lower scores indicate less severity. The second part of the questionnaire will include 6 categories (discomfort, mobility, self-care, anxiety, performance of activities, and sleeping). There will be 3 statements per category in which the patient is asked to indicate which statement best describes their current health. The questionnaire is scored by adding up the scores of each item to compute a total score.
次要结局
- Measured change in pain: VAS(12 months)